Chronic Ankle InstabilityNCT01196949
Comparing Manipulation and Rehabilitation to Rehabilitation Only, in the Management of Chronic Ankle Instability
A study testing Manipulative and Rehabilitative Therapy and Rehabilitative Therapy in people with Chronic Ankle Instability, run by Cleveland Chiropractic College at 1 site in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Manipulative and Rehabilitative Therapy and Rehabilitative Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with grade one (Grade I: evidence of minimal swelling with minimal dysfunction, point tenderness over joint, absence of positive anterior drawers sign) or grade two (Grade II: moderate amount of swelling and haemorrhage over the ankle with pain more do on weight bearing). Potentially positive anterior drawers sign but with no varus laxity CLAI (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).
- Participants between the ages of 18 - 45 years (Pellow and Brantingham, 2001; Chowdry et al, 2003; Parker, 2005).
- Participants that are clinically diagnosed as having CLAI: the presence of 4 or more of a combination of symptoms including lateral ankle pain, joint weakness, oedema (Tatro-Adams et al, 1995), joint crepitus, adhesions resulting in the formation of fixations in the joint and ligamentous laxity (Reid, 1992; Pellow and Brantingham, 2001; Ajis and Maffulli, 2006; McBride and Ramamurthy, 2006; Caulfield, 2007).
- Participants with a visual analogue scale (vas) (Liggins, 1982; Salaffi et al, 2003) score of between 20 and 70 millimetres to maintain homogeneity within the sample (Mouton, 1996).
- Participants with a foot/ankle disability Index (FADI) (Hale and Hertel, 2005) of between 50 and 90 to maintain homogeneity within the sample (Mouton, 1996).
- Participants with a berg balance scale (Kornetti et al, 2004) of less than 45/56 to maintain homogeneity within the sample (Mouton, 1996).
Show all 9Show fewer
- Participants must have the presence of fixations in either the mortise joint, the subtalar joint or the tarsals (Brantingham et al, 2007).
- Participants that give informed consent to participate in the research.
- Participants on muscle relaxants or any anti inflammatory medication will be required to have a wash out period of three days before participating in the study (Poul et al, 1993; Seth, 1999).
Who cannot join
- Participants who have experienced an acute injury or acute re-injury (prior to or during the study) will be excluded from the study because it does not comply with the six-week interval (i.e. chronic injuries) (Pellow and Brantingham, 2001).
- Participants with balance disorders of a neurological and/or otological and/or vascular cause of dizziness that may mimic instability and defective proprioception at the ankle level (Clark and Burden, 2005; Kynsberg et al, 2006).
- Participants with connective tissue disorders that create excessive generalised ligamentous laxity, participants with these conditions will not benefit from the treatment with generalised hyper laxity of ligaments.
- Participants with grade three CAI/ gross mechanical instability of the lateral ankle complex as the severity of this grade of injury usually requires surgical intervention and is unresponsive to conservative therapy (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).Grade III: severe swelling and haemorrhage with positive anterior drawers sign and rupture of ligamentous structures.
- Participants that are contraindicated to adjustments, which include but may not be limited to (Kirkaldy - Willis and Burton, 1992).
- Absolute contraindications, Destructive injury of the skeletal structures of the body; fractures and dislocations of all varieties; neurological damage as in Cauda equina syndrome, abdominal aortic aneurysm, referred pain of a visceral nature.
Show all 9Show fewer
- Relative Contraindications, bone demineralization, psychosomatic conditions, anticoagulant therapy and/or conditions where hemorrhaging may be present and Spondyloarthropathies.
- Participants with secondary manifestations of any of the following conditions, which may compromise balance/ proprioception, which are contraindicated to rehabilitation, which include and may not be limited to (Frontera, 1999).
- Dizziness that is present during the treatment Peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Durban University of Technology
Durban
Danella Lubbe, accounts@elconcranes.co.za
Ekta Lakhani, MTech: Chiro, ektal@dut.ac.za
About this study
Official title: The Effectiveness of Combined Manipulation and Rehabilitation Versus Rehabilitation Only, in the Management of Chronic Ankle Instability
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.
Read the detailed description
Rationale
- 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).
- 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.
- Conditions
- Chronic Ankle Instability
- Being tested
- Manipulative and Rehabilitative Therapy, Rehabilitative Therapy
- Keywords
- Ankle, Chronic, Instability, Manipulative, Rehabilitative, Manipulation, Rehabilitation
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulative and Rehabilitative TherapyOther
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.
Rehabilitative TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manipulative and Rehabilitative Therapy | Active comparator | Not described Receives: Other: Manipulative and Rehabilitative Therapy |
| Rehabilitative Therapy | Active comparator | Not described Receives: Other: Rehabilitative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Gold standard subjective pain scale
Measured: 3months
Secondary outcomes (1)
Foot Ankle Disability Index
General Ankle Function Assessment Tool
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Durban University of Technology
- Investigators
- James W Brantingham, Dc, PhD, Principal investigator, Cleveland Chiropractic CollegeDanella Lubbe, Principal investigator, Durban University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196949
- Sponsor's protocol ID
- CCC08132010A
- Status last verified
- Sep 2010
- First submitted
- 7 Sep 2010
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferran NA, Maffulli N. Epidemiology of sprains of the lateral ankle ligament complex. Foot Ankle Clin. 2006 Sep;11(3):659-62. doi: 10.1016/j.fcl.2006.07.002.
PubMed 16971255Balint GP, Korda J, Hangody L, Balint PV. Regional musculoskeletal conditions: foot and ankle disorders. Best Pract Res Clin Rheumatol. 2003 Feb;17(1):87-111. doi: 10.1016/s1521-6942(02)00103-1.
PubMed 12659823Delahunt, E. 2007. Neuromuscular contributions to functional instability of the ankle joint. Journal of Bodywork and Movement Therapies, 11:203-213.
Bozzelle, J.R. and Kishner, S. Recurrent Ankle Sprains. [Online] Available: http://emedicine.com, [Accessed August 2009].
Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin. 2006 Sep;11(3):531-7. doi: 10.1016/j.fcl.2006.07.004.
PubMed 16971246Reid, C.D. 1992. Sports Injury Assessment and Rehabilitation. United States of America: Churchill Livingston Inc
McBride DJ, Ramamurthy C. Chronic ankle instability: management of chronic lateral ligamentous dysfunction and the varus tibiotalar joint. Foot Ankle Clin. 2006 Sep;11(3):607-23. doi: 10.1016/j.fcl.2006.07.009.
PubMed 16971252Caulfield, B. 2000. Functional Instability of the Ankle Joint, features and underlying causes. Physiotherapy, 86:8
Lee AJ, Lin WH. Twelve-week biomechanical ankle platform system training on postural stability and ankle proprioception in subjects with unilateral functional ankle instability. Clin Biomech (Bristol). 2008 Oct;23(8):1065-72. doi: 10.1016/j.clinbiomech.2008.04.013. Epub 2008 Jul 14.
PubMed 18621453Pellow JE, Brantingham JW. The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains. J Manipulative Physiol Ther. 2001 Jan;24(1):17-24. doi: 10.1067/mmt.2001.112015.
PubMed 11174691Green T, Refshauge K, Crosbie J, Adams R. A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains. Phys Ther. 2001 Apr;81(4):984-94.
PubMed 11276181van der Wees PJ, Lenssen AF, Hendriks EJ, Stomp DJ, Dekker J, de Bie RA. Effectiveness of exercise therapy and manual mobilisation in ankle sprain and functional instability: a systematic review. Aust J Physiother. 2006;52(1):27-37. doi: 10.1016/s0004-9514(06)70059-9.
PubMed 16515420Brantingham JW, Globe G, Pollard H, Hicks M, Korporaal C, Hoskins W. Manipulative therapy for lower extremity conditions: expansion of literature review. J Manipulative Physiol Ther. 2009 Jan;32(1):53-71. doi: 10.1016/j.jmpt.2008.09.013.
PubMed 19121464
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Combined Manipulation and Rehabilitation Versus Rehabilitation Only, in the Management of Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT01196949
- Acronym / sponsor ID
- CCC08132010A
- Conditions
- Chronic Ankle Instability
- Keywords
- Ankle, Chronic, Instability, Manipulative, Rehabilitative, Manipulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cleveland Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Durban University of Technology
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulative and Rehabilitative Therapy | Active comparator | Other: Manipulative and Rehabilitative Therapy |
| Rehabilitative Therapy | Active comparator | Other: Rehabilitative Therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants with grade one (Grade I: evidence of minimal swelling with minimal dysfunction, point tenderness over joint, absence of positive anterior drawers sign) or grade two (Grade II: moderate amount of swelling and haemorrhage over the ankle with pain more do on weight bearing). Potentially positive anterior drawers sign but with no varus laxity CLAI (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).
- Participants between the ages of 18 - 45 years (Pellow and Brantingham, 2001; Chowdry et al, 2003; Parker, 2005).
- Participants that are clinically diagnosed as having CLAI: the presence of 4 or more of a combination of symptoms including lateral ankle pain, joint weakness, oedema (Tatro-Adams et al, 1995), joint crepitus, adhesions resulting in the formation of fixations in the joint and ligamentous laxity (Reid, 1992; Pellow and Brantingham, 2001; Ajis and Maffulli, 2006; McBride and Ramamurthy, 2006; Caulfield, 2007).
- Participants with a visual analogue scale (vas) (Liggins, 1982; Salaffi et al, 2003) score of between 20 and 70 millimetres to maintain homogeneity within the sample (Mouton, 1996).
- Participants with a foot/ankle disability Index (FADI) (Hale and Hertel, 2005) of between 50 and 90 to maintain homogeneity within the sample (Mouton, 1996).
Key exclusion criteria (9 listed)
- Participants who have experienced an acute injury or acute re-injury (prior to or during the study) will be excluded from the study because it does not comply with the six-week interval (i.e. chronic injuries) (Pellow and Brantingham, 2001).
- Participants with balance disorders of a neurological and/or otological and/or vascular cause of dizziness that may mimic instability and defective proprioception at the ankle level (Clark and Burden, 2005; Kynsberg et al, 2006).
- Participants with connective tissue disorders that create excessive generalised ligamentous laxity, participants with these conditions will not benefit from the treatment with generalised hyper laxity of ligaments.
- Participants with grade three CAI/ gross mechanical instability of the lateral ankle complex as the severity of this grade of injury usually requires surgical intervention and is unresponsive to conservative therapy (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).Grade III: severe swelling and haemorrhage with positive anterior drawers sign and rupture of ligamentous structures.
- Participants that are contraindicated to adjustments, which include but may not be limited to (Kirkaldy - Willis and Burton, 1992).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manipulative and Rehabilitative TherapyParticipants 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. | Other | Manipulative and Rehabilitative Therapy |
| Rehabilitative TherapyParticipants 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. | Other | Rehabilitative Therapy |
Primary outcome
Visual Analogue Scale
Time frame: 3months
Gold standard subjective pain scale
1 secondary outcome
Foot Ankle Disability Index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
- Background: PubMed 16971255Ferran NA, Maffulli N. Epidemiology of sprains of the lateral ankle ligament complex. Foot Ankle Clin. 2006 Sep;11(3):659-62. doi: 10.1016/j.fcl.2006.07.002.
- Background: PubMed 12659823Balint GP, Korda J, Hangody L, Balint PV. Regional musculoskeletal conditions: foot and ankle disorders. Best Pract Res Clin Rheumatol. 2003 Feb;17(1):87-111. doi: 10.1016/s1521-6942(02)00103-1.
- BackgroundDelahunt, E. 2007. Neuromuscular contributions to functional instability of the ankle joint. Journal of Bodywork and Movement Therapies, 11:203-213.
- BackgroundBozzelle, J.R. and Kishner, S. Recurrent Ankle Sprains. [Online] Available: http://emedicine.com, [Accessed August 2009].
- Background: PubMed 16971246Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin. 2006 Sep;11(3):531-7. doi: 10.1016/j.fcl.2006.07.004.
- BackgroundReid, C.D. 1992. Sports Injury Assessment and Rehabilitation. United States of America: Churchill Livingston Inc
- Background: PubMed 16971252McBride DJ, Ramamurthy C. Chronic ankle instability: management of chronic lateral ligamentous dysfunction and the varus tibiotalar joint. Foot Ankle Clin. 2006 Sep;11(3):607-23. doi: 10.1016/j.fcl.2006.07.009.
- BackgroundCaulfield, B. 2000. Functional Instability of the Ankle Joint, features and underlying causes. Physiotherapy, 86:8
- Background: PubMed 18621453Lee AJ, Lin WH. Twelve-week biomechanical ankle platform system training on postural stability and ankle proprioception in subjects with unilateral functional ankle instability. Clin Biomech (Bristol). 2008 Oct;23(8):1065-72. doi: 10.1016/j.clinbiomech.2008.04.013. Epub 2008 Jul 14.
- Background: PubMed 11174691Pellow JE, Brantingham JW. The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains. J Manipulative Physiol Ther. 2001 Jan;24(1):17-24. doi: 10.1067/mmt.2001.112015.
- Background: PubMed 11276181Green T, Refshauge K, Crosbie J, Adams R. A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains. Phys Ther. 2001 Apr;81(4):984-94.
- Background: PubMed 16515420van der Wees PJ, Lenssen AF, Hendriks EJ, Stomp DJ, Dekker J, de Bie RA. Effectiveness of exercise therapy and manual mobilisation in ankle sprain and functional instability: a systematic review. Aust J Physiother. 2006;52(1):27-37. doi: 10.1016/s0004-9514(06)70059-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James W Brantingham, Dc, PhD principal investigator
Cleveland Chiropractic College
Danella Lubbe principal investigator
Durban University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulative and Rehabilitative Therapy and Rehabilitative Therapy in people with Chronic Ankle Instability, run by Cleveland Chiropractic College at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James W Brantingham, DC, PhD (323.-906-2189, james.brantingham@cleveland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196949, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2010.