Does Mulligan's anterior-to-posterior talar glide is effective in improving dorsiflexion in subjects with acute ankle inversion sprain than Maitland's anterior-to-posterior talar glide mobilization. Design: Experimental, Comparative, Randomized Controlled Trail-single blinded study. Participants: 90 samples with acute ankle inversion sprain diagnosed by radiologist through X-Ray imaging will be collected with convenience sampling. Intervention: Based on inclusion and exclusion criteria subjects randomly allocated to 3 groups of intervention- Group I - Mulligan's anterior-to-posterior talar glide along with RICE, Group II - Maitland's anterior-to-posterior talar glide along with RICE, Group III - RICE (control group) for 2 weeks. Outcome Measures: Pre and Post session, measurement of dorsiflexion range of motion will be taken with Modified Lidcombe templates. Duration: The expected duration of study is considered 8months for ethical clearance, data collection and analysis, editing and publishing. Budget: An estimation of Rs 30,000 is made including the investigation, instruments, materials and refreshments.
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Ankle is a complex joint which is categorized as a hinge joint. It is one of the important component for ambulation in humans. Ankle sprains are one of the commonest injuries in athletics. It accounts for 20% of all sports injuries (Bergfeld J; 2004).In India, incidence rate of ankle sprain accounts for 0.31% of the population and the chances of re-injury is seen as high as 78-80% despite the continued research in this field (Statistics for ankle sprain; 2003).
The pathomechanics for ankle inversion injury is inversion and plantar flexion of the ankle joint. There is loss of dorsiflexion and inversion range of motion which is attributed to pain and swelling (Denegar CR et al; 2002), (Collins et al; 2004).According to Denegar C et al (2002) the loss of dorsiflexion range of motion is due to restriction of posterior talar glide. This suggests that in an acute ankle inversion sprain the loss of dorsiflexion range of motion could be due to mechanical dysfunction in talocrural joint.
The conventional treatment for acute ankle sprain is RICE (rest, ice, compression, elevation).The main aim of conventional treatment (RICE) is primarily to reduce pain and inflammation (Starkey JA; 1976), (Slatyer MA et al; 1997). The conventional treatment (RICE) with early movement is found to be more effective for reducing pain, swelling and improving mobility (Dettori et al; 1994). Because of the ineffectiveness of conventional treatment for treating the positional dysfunction caused due to acute ankle inversion injury the joint becomes more susceptible to injury (Hertel J et al, 1999).
Manual Therapy focuses on reduction of pain and correction of the postural and movement dysfunction due to ankle sprain. According to Maitland grades of mobilization grade I and II mobilization is used in acute condition and grade II mobilization is seem effective in reducing pain and improving dorsiflexion range of movement in acute musculoskeletal conditions. Maitland grades of mobilization improves the ankle dorsiflexion in acute ankle inversion sprain (Green et al; 2001) and reduces pain by modulation of nervous tissue (Vincenzino B et al; 1998). According to Maitland GD (1986), passive joint mobilization improves the range of movement by gentle oscillatory movement of the articular surfaces that creates movement of the mobile segments by a means other than the muscles .According to Collins et al (2004), Mulligan's mobilization with movement technique is effective in reducing pain and improves dorsiflexion of ankle joint. A single case study done by O Brien, B.Vincenzino (1998) showed that Mulligan Mobilization with movement technique on acute ankle sprain improved the range of movement (dorsiflexion and inversion), functional outcome and reduced the pain. According to pilot study conducted by John-Mark Chesney, Erin Morris, Mulligan's mobilization with movement technique and taping had significant effect on temporal and spatial parameters of gait. Immediate decrease in pain and an early return to function are claimed to be result of Mulligan's mobilization with movement Mulligan 1995; Vincenzino Wright 1995; Hetherington 1996). However, the lack of adequate evidence in literature for the effectiveness of Mulligan's anterior-to-posterior talar glide with movement technique in acute ankle inversion sprain failed to prove its clinical and statistical significance in research methods. The above literature also shows lack of studies done to compare the effects of Maitland and Mulligan mobilization technique in treatment of acute ankle inversion sprain.
Hence, the aim of the study is to find the immediate effect of Mulligan's anterior-to-posterior talar mobilization with movement technique in acute ankle inversion sprain with RICE and compare the results with that of Maitland anterior-to-posterior talar glide mobilization with RICE for treatment of acute ankle inversion sprain.
REVIEW OF LITERATURE
Ankle joint is a complex joint due to its articular, ligamentous and tendinous anatomy. The anterior talofibular ligament restricts anterior translation and internal rotation of talus inside the mortise. The coupled motion during plantar flexion happens as internal rotation and anterior translation of talus aided by deltoid ligament. The calcaneofibular ligament restricts inversion of the talocrural and subtalar joint. The posterior talofibular ligament restricts inversion and internal rotation after calcaneofibular ligament and anterior talofibular ligament undergo injury.
According to Konradsen and Voight (2002) an inversion torque was produced on loading a cadaveric leg, when the unloaded foot was positioned in 30 degree inversion, full plantar flexion and 10 degree internal tibial rotation. The collision with 20 degree inverted foot in swing phase follow through forced the foot into full limit of inversion, plantar flexion and internal tibial rotation.
According to Denegar CR et al (2002) in normal biomechanics the instantaneous axis of rotation of talocrural joint translates posteriorly during dorsiflexion, but in anterior malaligned talus or with restricted posterior talar glide the axis of rotation is shifted anteriorly leading to joint dysfunction.
According to Baumhauer JF et al (1995) previous history of sprain, limited range of motion and reduced dorsiflexor and plantar flexor strength ratio, elevated eversion to inversion ratio have been attributed to predisposing to inversion injury.
According to Eren OT et al (2003) high malleolar index (posteriorly positioned fibula) is attributed to predisposing factor to sprain. Average malleolar index was +11.5 degree in subjects with ankle sprain and +5.85 degree in normal controls.
Green T in 2001 used a Modified Lidcombe Template to measure the pain free dorsiflexion range of motion occurring in talocrural joint. The template consisted of 2 boards joined by an adjustable hinge. One board served as a footplate and other was placed under the subject's calf. The adjustable hinge served as the axis of rotation of template in vertical plane and the board placed under the subject's calf allowed for adjustment in horizontal plane. The measurement was standardized by measuring both force applied and the angle of dorsiflexion at which the subject first experienced the pain (Matyas T, Bach T; 1985). The force applied was standardized throughout the trail by spring balance and the direction of force was standardized by spirit level attached to the spring. The device showed high intrarater and interrater reliability of which 29% were in exact agreement and 84.5% were within 2 degrees, ICC=0.94.
The conventional management of ankle sprain is RICE in acute stage of injury. The functional treatment procedures with early initiation of weight bearing as tolerated, early mobilization, proprioceptive training, balance training has been advocated to provide early functional rehabilitation to subjects.
According to Bahr R (2004) and Bruce Beynnon B, (2004) the management of sprain concentrates on static and dynamic stability, gaining normal ankle range of motion, optimal strength of peroneal, dorsiflexors, plantar flexors, and invertor muscles of ankle and retraining ankle strategy.
According to Kerkhoffs et al (2002) functional treatment is superior to immobilization and surgical intervention in areas of pain on activity, quality of performance on return to sport/work, objectives instability on x-ray views and patient satisfaction.
Manual therapy in ankle inversion sprain
Green et al (2001) conducted a randomized controlled trial of passive accessory joint mobilization on acute ankle inversion sprain. The study included 38 subjects with acute ankle inversion sprain(<72hours)and were randomly assigned to control group(RICE) and experimental group(anterior-to-posterior mobilization and RICE).Treatment was given every 2days for maximum 2weeks.The treatment technique used in this study was Maitland's grade 3 anterior to posterior talar glide of talus. Results showed that dorsiflexion improved earlier in experimental group as compared to the control group.
Elizabeth L et al (2008) conducted a study in which 10 subjects were taken with immobilized ankle for at least 14 days and presented with at least 5 degree of dorsiflexion deficit compared to contralateral ankle. A crossover design was employed and subjects received Maitland's grade 3 mobilization in one group and control intervention (no treatment) in other group. Results showed that joint mobilization led to a reduction in pain and improvements in pain-free dorsiflexion.
Mulligan mobilization with movement technique
Collins et al (2004) conducted a double-blinded randomized controlled trial with a crossover design approach. In this study 14 subjects with grade 2 ankle sprain were taken. The dorsiflexion in weight-bearing and thermal pain threshold were calculated. All the subjects undergo 3 treatment conditions-Mulligan's mobilization with movement technique for dorsiflexion, placebo group and control group (no treatment).Results showed that the talar anterior-to-posterior glide improved the recovery rate in treatment with Mulligan's mobilization with movement technique.
The study conducted by Collins N was done on subjects with sub acute ankle sprain.
T O'Brien, B.Vincenzino (1998) conducted a single case study to investigate the effects of Mulligan's with movement technique mobilization for acute lateral ankle sprain. The technique used in this study was posterior glide to distal fibular while patient actively inverted the ankle. In the study 2 subjects with acute ankle sprain were used to control for natural resolution of ankle sprain. Subject I underwent ABAC protocol while subject II BABAC protocol where A was no treatment phase B was treatment phase and C was post treatment return to sport phase. The outcome measures Modified Kaikkonen test functional outcome, VAS for pain and range of dorsiflexion and inversion were measured pre and post of each intervention session. Results showed rapid improvement of range of motion (inversion and dorsiflexion) and immediate decrease in pain.
Hence from the above studies we can infer that anterior-to-posterior talar glide technique in both Maitland and Mulligan mobilization is effective in treating ankle inversion sprain than the RICE protocol alone. The above studies also infer that Maitland's grades of mobilization is significantly effective in improving dorsiflexion range in acute ankle sprain. However, Mulligan's mobilization had shown effective results in treating ankle sprain in subacute condition. The study done by T O'Brien, B.Vincenzino (1998) shows the effectiveness of Mulligan's mobilization with movement technique in improving dorsiflexion range of motion in acute ankle sprain but the study design leads to limitation of generalization of its findings. However, it does provide the knowledge to conduct a random clinical trail in utility of Mulligan's mobilization with movement technique in the treatment of acute ankle inversion sprain and to compare the results with Maitland's grades of mobilization to find the best effective treatment method for improving the recovery rate in acute ankle inversion sprain.
IDENTIFICATION OF RESEARCH PROPOSAL QUESTION
Does Mulligan's anterior-to-posterior talar glide is effective in improving dorsiflexion in subjects with acute ankle inversion sprain than Maitland's anterior-to-posterior talar glide mobilization.
Mulligan's anterior-to-posterior talar glide is effective than Maitland's grades of mobilization in improving dorsiflexion range of motion in subjects with acute ankle inversion sprain.
Mulligan's anterior-to-posterior talar glide is not effective than Maitland's grades of mobilization in improving dorsiflexion range of motion in subjects with acute ankle inversion sprain.
An Experimental, Comparative, Randomized Controlled Trail design. The study will be single blinded to avoid any possible bias. The subjects will be allocated to 3 group of interventions-Mulligan's anterior-to-posterior talar glide with movement technique with RICE, Maitland's anterior-to-posterior talar glide mobilization with RICE, and third group RICE alone .Outcome measure will measure the degree of dorsiflexion pre and post to each session which will be measured by the assessor blinded to the allocation of subjects to the groups.
The study will be conducted by recruiting 90 samples through convenience sampling by giving advertisements and notices to orthopaedic and physiotherapy department in MS Ramaiah Memorial hospital and the hospitals nearby its surrounding areas. The subjects recruited will be diagnosed for acute ankle inversion sprain and referred by radiologist through X-Ray imaging. To maintain the homogeneity of the groups all the subjects will be recruited based on Inclusion and exclusion criteria. Inclusion criteria-All subjects of age group 20-30years of age, History of ankle inversion injury with pain over lateral aspect of ankle (<72hours) of injury, deficit of at least 5 degrees of dorsiflexion, subjects are able to partial weight bear on affected ankle, pain, swelling and tenderness over lateral aspect of ankle. Exclusion criteria-Subjects having ankle fracture, any history of previous surgery or sprain on affected leg, any intake of anti-inflammatory or anti-coagulants post injury ,subjects with vascular diseases.
The ethical approval will be taken from Ethical Board of MS Ramaiah Memorial Hospital along with the permission of other hospitals near by its surroundings. Subjects will be given a copy of informed consent with the details of the study and the confidentiality of patient's personnel information and data obtained after the study will be maintained. Subjects can withdraw from study at any given point of time.
VENUE/LOCATION OF THE STUDY
The study will be conducted in MS Ramaiah Memorial Hospital Physiotherapy Department, Bangalore.
A RANDOMIZED CONTROLLED TRAIL STUDY
An experimental randomized controlled trail -single blinded study will be conducted on 90 subjects with acute ankle inversion sprain. The technique of the interventions will be finalized during the study and side-effects or any error in the intervention will be noted and rectified.
RESEARCH METHOD AND EXPERIMENTAL INTERVENTION
90 samples will be recruited by convenience sampling. The samples will be assessed for acute ankle inversion sprain by X-Ray imaging done by the radiologist in radiology department of MS Ramaiah Memorial Hospital. The subjects will be randomly assigned to 3 groups by chit method.
Each group will be assigned 30 subjects. The researcher who will conduct the study is a qualified physiotherapist who specializes in manual therapy. After the allocation of the group the experimental group I will receive Mulligan's anterior to posterior talar glide along with active dorsiflexion of ankle which will be followed by RICE application. The mobilization will be performed in weight bearing in which the therapist applies a postero-anterior force to distal leg through a treatment belt while stabilizing the foot and talus (Mulligan; 1999).The experimental group II will receive Maitland's anterior-to-posterior talar glide (Grade II) followed by RICE application. The mobilization will be performed with subject lying supine and the ankle will be positioned over the edge of plinth with proximal hand of therapist stabilizing the distal tibia and fibula while the distal hand will mobilize the talus with posteriorly directed oscillation(Maitland;1977).Group III will receive RICE treatment for maximum of 2 weeks. Subjects in experimental group I and II will be treated every second day for maximum of 2 weeks. Therefore 6 sessions of treatment over 14 days will be done. Three sets of 10 repetitions will be applied with 1 minute between sets (Exelby, 1996) in both mobilization technique. Pain experienced during treatment will result in immediate cessation of technique and exclusion of the subject from study.
Dorsiflexion range of motion will be measured by Modified Lidcombe template. The template enabled standardized measurement of dorsiflexion range of movement. The axis of rotation of ankle was aligned with adjustable axis of rotation of template. The spring balance attached to the footplate measure the force applied in the standardized direction. A hydrogoniometer placed on the footplate measures the range of dorsiflexion in degrees. The template have a high intrarater and interrater reliability of which 29% were in exact agreement and 84.5% were within 2 degrees, ICC=0.94. Hydrogoniometer have high intraclass coefficients (0.84-0.99) which revealed high agreement between the raters (Lex D.De jong et al; 2007)
RESULTS AND DATA ANALYSIS
The dorsiflexion range of movement measured will be in degrees which represent a parametric data. The data collected pre and post of each 6 session in group I and group II will be analyzed by related t test (i.e. within the group) and unrelated t test will be done to compare between the group I and group II for dependent variable. One way ANOVA will be used for analysis of data from all the 3 groups along with Scheffe test to find the most effective group for treatment of acute ankle inversion sprain. The level of significance will be set at 0.5; the probability will be calculated based on the t value with degree of freedom table. The confidence interval will be kept to 95%.
The overall estimated time required for the completion of the study is 8months i.e. 1 month for ethical clearance, 4 months for the randomized controlled trail, data collection and data analysis, 1 month for writing up and presenting results and 2 months for publishing results.
Randomized controlled trail & amend data collection tools
Writing up & presenting results
The overall estimation of the budget is Rs30, 000 which includes
X-RAY imaging - Rs20, 000 (90 subjects)
Modified Lidcombe Template and hydrogoniometer - Rs5000
Stationary - Rs1000
Transportation and refreshments - Rs4000
This is an informed consent given to a subject who wishes to participate in research study.
Please red the informed consent carefully or you can ask anyone of your relative who you trust can read this informed consent for you in your language by translating it.
Please feel free to ask any questions you have about this informed consent or research study in your mind.
Please sign the consent form only after you have no doubts about the research study or consent form. Do not sign the consent form under any kind of pressure.
Title of Research Project
Immediate effects of Mulligan's anterior-to-posterior talar glide with movement technique versus Maitland's anterior-to-posterior talar glide for pain free dorsiflexion in acute ankle inversion sprain.
M. Sc in Clinical Physiotherapy.
Purpose Of Study
Acute ankle sprain has high percentage re-injury. Mulligan's mobilization with movement technique helps in improving dorsiflexion range of motion by correction of positional dysfunction of joint. This study is to find the effect of Mulligan's mobilization with movement technique and compare it with effects of Maitland's grades of mobilization in treatment of acute ankle inversion sprain.
Description of Study
After being diagnosed with acute ankle inversion sprain you will be sent to the physiotherapy department in physiotherapy department. The researcher will explain you about the treatment technique and the study and an informed consent will be given to you based on your decision your participation will be decided. If you wish to participate a treatment technique selected for the respective group in which you will allocated will be performed on you and the assessment will be taken before and after the treatment session. The duration of treatment is 2 weeks and if there is any changes, you will be informed prior.
Possible Risks or Complication
The treatment technique itself has no side-effects or complication and it will be performed by a qualified physiotherapist in Manual Therapy.
If the therapy is not effective to you, you will be provided with an alternative treatment with free of cost.
All the expenses regarding the research work including the investigation, transportation, food expenses and treatment will be free of cost.
The study may be beneficial to society and individuals of similar condition.
You can benefit by improving you condition with help of this treatment.
Participation in this research study is voluntary. If the participant wants to withdraw he/she can withdraw at any given point of time.
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research and understand that I have the right to withdraw from the research at any time without in any way affecting my medical care.
Name of the participant _____________________
Signature of participant _____________________
A literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team).
I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.
Name of witness ___________________ AND
Thumb print of participant
Signature of witness ___________________
I have accurately read or witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.
Print Name of Researcher _________________
Signature of Researcher ___________________
A copy of this Informed Consent Form has been provided to participant ____________ (initialed by the researcher/assistant)
For more information contact:
M. Sc in clinical physiotherapy,
MS Ramaiah Memorial Hospital,
Site of Disorder :
Mode of Treatment :
Dorsiflexion range of motion
Signature of Clinician :
Signature of Chief Physiotherapist :
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