Other Biomechanical LesionsNCT01121952
The Effect of Manipulation on Dysfunction of the Talo-crural Joint
A study testing Chiropractic (HVLA) manipulation in people with Other Biomechanical Lesions and Talo-crural Joint Dysfunction, run by Scandinavian College of Chiropractic at 1 site in Sweden.
Trial summary
The purpose of this trial was to explore the effects of chiropractic manipulation in patients with talo-crural joint dysfunction. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Other Biomechanical Lesions, Talo-crural Joint Dysfunction
- What is being tested?
- Chiropractic (HVLA) manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2009to Apr 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First league handball player
- Talo-crural joint dysfunction
- Age >16 yrs
Who cannot join
- Patients with a history of recent trauma or previous operations with remaining fixation material in the foot or ankle
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Scandinavian College of Chiropractic
Solna, Stockholm County, 169 57
About this study
Official title: The Effect of Manipulation on Dysfunction of the Talo-crural Joint- a Clinical Randomised Trial
The purpose of this trial was to explore the effects of chiropractic manipulation in patients with talo-crural joint dysfunction.
Read the detailed description
Ankle sprains is one of the most common problems in clinical practice, mostly due to loss of mobility. Factors affecting the mobility of the joints may be due to muscle tension, ligamentous or anatomical anomalies.
Research over the last years have reported a scarce of trials investigating chiropractic treatment of the ankle joint. Previous studies have focused on investigating ROM and proprioception. This study aimed to determine whether a single high-velocity, low-amplitude (HVLA) thrust manipulation to the talo-crural joint altered ankle function in subjects with dysfunction of the talo-crural joint.
- Being tested
- Chiropractic (HVLA) manipulation
- Keywords
- Ankle joint, Talo-crural joint, Vertical jump, Chiropractic manipulation (HVLA), ROM, Proprioception, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic (HVLA) manipulationOther
Single high-velocity, low-amplitude (HVLA long axis) thrust manipulation to the talo-crural joint, once a week during a three week period
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single high-velocity, low-amplitude (HVLA) thrust manipulation towards Tibia, not affecting the dysfunctional talo-crural joint Receives: Other: Chiropractic (HVLA) manipulation |
| Treatment | Experimental | Single high-velocity, low-amplitude (HVLA long axis) thrust manipulation on dysfunctional talo-crural joint Receives: Other: Chiropractic (HVLA) manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counter movement jump; IVAR test system
First assessment: One leg single jump before and after treatment (active or placebo)
Measured: Day 1
Secondary outcomes (2)
Counter movement jump; IVAR test system
Second assessment: Active or placebo treatment if needed
Measured: Week one
Counter movement jump; IVAR test system
Third assessment: One leg single jump before and after treatment (active or placebo
Measured: Week two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Biomechanical LesionsStudies 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
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scandinavian College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Håkan A Westerblad, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121952
- Sponsor's protocol ID
- 2009/1965-31/4
- Status last verified
- Apr 2010
- First submitted
- 9 Apr 2010
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manipulation on Dysfunction of the Talo-crural Joint- a Clinical Randomised Trial
- ClinicalTrials.gov ID
- NCT01121952
- Acronym / sponsor ID
- 2009/1965-31/4
- Keywords
- Ankle joint, Talo-crural joint, Vertical jump, Chiropractic manipulation (HVLA), ROM, Proprioception, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Scandinavian College of ChiropracticUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 12 May 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.
The purpose of this trial was to explore the effects of chiropractic manipulation in patients with talo-crural joint dysfunction.
Detailed description
Ankle sprains is one of the most common problems in clinical practice, mostly due to loss of mobility. Factors affecting the mobility of the joints may be due to muscle tension, ligamentous or anatomical anomalies.
Research over the last years have reported a scarce of trials investigating chiropractic treatment of the ankle joint. Previous studies have focused on investigating ROM and proprioception. This study aimed to determine whether a single high-velocity, low-amplitude (HVLA) thrust manipulation to the talo-crural joint altered ankle function in subjects with dysfunction of the talo-crural joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Chiropractic (HVLA) manipulationSingle high-velocity, low-amplitude (HVLA) thrust manipulation towards Tibia, not affecting the dysfunctional talo-crural joint |
| Treatment | Experimental | Other: Chiropractic (HVLA) manipulationSingle high-velocity, low-amplitude (HVLA long axis) thrust manipulation on dysfunctional talo-crural joint |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- First league handball player
- Talo-crural joint dysfunction
- Age >16 yrs
Key exclusion criteria (1 listed)
- Patients with a history of recent trauma or previous operations with remaining fixation material in the foot or ankle
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 |
|---|---|---|
| Chiropractic (HVLA) manipulationSingle high-velocity, low-amplitude (HVLA long axis) thrust manipulation to the talo-crural joint, once a week during a three week period | Other | Placebo, Treatment |
Primary outcome
Counter movement jump; IVAR test system
Time frame: Day 1
First assessment: One leg single jump before and after treatment (active or placebo)
2 secondary outcomes
Counter movement jump; IVAR test system
Time frame: Week one
Counter movement jump; IVAR test system
Time frame: Week two
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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.
Håkan A Westerblad, MD, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic (HVLA) manipulation in people with Other Biomechanical Lesions and Talo-crural Joint Dysfunction, run by Scandinavian College of Chiropractic at 1 site in Sweden.
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 3 inclusion and 1 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 12 May 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Counter movement jump; IVAR test system (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2010.