Comparing Manipulation and Rehabilitation to Rehabilitation Only, in the Management of Chronic Ankle Instability
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|ClinicalTrials.gov Identifier: NCT01196949|
Recruitment Status : Unknown
Verified September 2010 by Cleveland Chiropractic College.
Recruitment status was: Recruiting
First Posted : September 9, 2010
Last Update Posted : September 27, 2010
It is hypothesized that a combination approach would produce increased clinically and statistically significant outcomes as opposed to standard single intervention, inclusive of comparatively greater reduction in pain, improvement in range of motion, proprioception and function with an associated quicker recovery time.
Chronic ankle instability (CAI) is a frequently encountered condition of the musculoskeletal system. Various individual treatment options have previously been compared to one another in clinical trials, however there is paucity of literature with regards to combined treatment choices versus individual therapy. The purpose of this study is to investigate the relative effectiveness of combined manipulation and rehabilitation versus rehabilitation only, in the management of CAI.
The study will be conducted as a single blinded randomised and comparative clinical trial at Cleveland Chiropractic College and Durban University of Technology.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Ankle Instability||Other: Manipulative and Rehabilitative Therapy Other: Rehabilitative Therapy||Not Applicable|
- Inversion ankle sprains are the most frequently encountered injury to the ankle (Ferran and Maffulli, 2006) especially in the realm of the sporting arena (Balint et al, 2003; Delahunt, 2007; Bozzelle and Kishner, 2008). Up to 40 % of these acutely injured participants will progress to a state of chronic ankle instability (CAI) (Verhagen et al, 1995; Balint et al, 2003; Ajis and Maffulli, 2006; Ajis et al, 2006). Therefore the lateral ankle as well as the management of CAI requires further investigation with regard to treatment options.
- Peroneal muscle weaknesses as well as proprioceptive deficits have been universally encountered in cases of CAI (Reid, 1992; Delahunt, 2007). Studies have indicated that coupled peroneal muscle strengthening and proprioception training of the ankle are seen as the most efficient means of rehabilitation for CAI (Reid, 1992; Ajis et al, 2006; Ajis and Maffulli, 2006; McBride and Ramamurthy, 2006; Caulfield, 2007; Lee and Lin, 2008). Pellow and Brantingham, (2001) and Gillman, (2004) have reported that manipulation is also a successful intervention tool for the treatment of CAI, documenting a statistically significant reduction in pain (p=0.007), improved range of motion (p=0.199) in the ankle joint as well as improved general functioning of the ankle (p=0.004). It has been identified that there are three components (Richie, 2001; Sefton et al, 2008) that contribute to the persistence of CAI namely joint fixations (in the mortise and subtalar joint) as well as muscular (Richie, 2001) and proprioceptive alterations (Richie, 2001; Delahunt, 2007).
- It is hypothesised that a combination approach would produce increased clinically and statistically significant outcomes as opposed to standard single intervention, inclusive of comparatively greater reduction in pain, improvement in range of motion, proprioception and function with an associated quicker recovery time (Green et al, 2001; Eisenhart et al, 2003; Collins,2004; Vicenzino et al, 2006). There are insufficient studies, particularly high quality studies, with the required methodology, to make a definitive decision regarding whether this is supported (Van der Wees et al, 2006; Whitman et al, 2009). Additionally chiropractors will typically manage a participant with CAI with a combination of manipulation and rehabilitation, at present no research using such combined therapy by chiropractors has yet been published (Brantingham et al, 2009).
3. Research Problem and Aims The aim of the study is to investigate the relative effectiveness of a combination of manipulation and rehabilitation as compared to rehabilitation only in the treatment for CAI, in terms of participantive and objective clinical assessments.
The specific objectives of the study are:
- To determine the relative effectiveness of manipulation and rehabilitation versus rehabilitation only, to the ankle joint in terms of objective assessments (algometer, berg balance scale, weight bearing ankle dorsiflexion test and foot and ankle disability index in participants experiencing CAI syndrome).
- To determine the relative effectiveness of manipulation and rehabilitation versus rehabilitation only, to the ankle joint in terms of participantive assessments (visual analogue scale and motion palpation) in participants experiencing CAI syndrome.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effectiveness of Combined Manipulation and Rehabilitation Versus Rehabilitation Only, in the Management of Chronic Ankle Instability|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||November 2010|
|Active Comparator: Manipulative and Rehabilitative Therapy||
Other: Manipulative and Rehabilitative Therapy
Participants will receive 6 treatments over a 3 to 5 week time frame. A minimum of one day and maximum of 3 days between treatments. This group will receive high velocity low amplitude thrust to a minimum of 1 and maximum of 3 restricted segments within the mortise joint, subtalar joint and tarsal along with the same rehabilitation protocol as the other group.
|Active Comparator: Rehabilitative Therapy||
Other: Rehabilitative Therapy
Participants will receive education and training in the home exercises. This group is only required to attend the treatment facility for outcome measure readings and if they have any questions about the research protocol or check if they are performing their exercises correctly. A Theraband will be utilized for the peroneal muscle strengthening; 3 sets of 12 repetitions. Proprioception will be conducted on a Bosu Ball; 10 minutes per period. This protocol will be conducted everyday at home for the 5 week study. A diary will be required to record compliance and indicate how exercises should be performed.
- Visual Analogue Scale [ Time Frame: 3months ]Gold standard subjective pain scale
- Foot Ankle Disability Index [ Time Frame: 3 months ]General Ankle Function Assessment Tool
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196949
|Contact: James W Brantingham, DC, PhDfirstname.lastname@example.org|
|Durban University of Technology||Recruiting|
|Durban, South Africa|
|Contact: Danella Lubbe email@example.com|
|Contact: Ekta Lakhani, MTech: Chiro firstname.lastname@example.org|
|Principal Investigator: Danella Lubbe|
|Principal Investigator:||James W Brantingham, Dc, PhD||Cleveland Chiropractic College|
|Principal Investigator:||Danella Lubbe||Durban University of Technology|