Thumb Joint StiffnessNCT01082432
Electrical Stimulation to Recover Greater Range of Motion After Surgery
An observational study of Thumb Joint Stiffness, run by Université Joseph Fourier at 1 site in France.
Trial summary
Background One of the potentially debilitative complications of operative repair and subsequent immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent such a physical impairment, active joint mobilization has shown to be efficient. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thumb Joint Stiffness
- What is being tested?
- electrically induced muscle activation
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Aug 2009
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hand physical therapy center
Who may be able to join
- loss of range of flexion in the involved metacarpophalangeal joint of at least ten degrees when compared to the opposite thumb
- more than eight weeks post-surgery
Who cannot join
- do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Université Joseph Fourier - TIMC IMAG laboratory
La Tronche, 38700
About this study
Official title: Superimposed Electrical Stimulation Real-time Effects on Repeated Muscle Contractions Enable to Increase Recovery From Thumb Joint Stiffness After Surgery of the Ulnar Collateral Ligament
Background
One of the potentially debilitative complications of operative repair and subsequent immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent such a physical impairment, active joint mobilization has shown to be efficient. However, adhesions sometimes remain despite the therapy. Due to the viscoelastic nature of the biological tissues, if a technique can enable to extend the muscle ability to impose a maximal steady stress on adhesions, adhesion deformation should be greater and range of motion deficit should be reduced. Within that context, the purpose of the present study was to assess the real-time effects of superimposed electrical stimulation (SES) on maximal voluntary muscular contraction (VOL) over time and to assess SES effects on range of motion recovery in thumb stiff joint.
Read more
Methods and Findings
The aim of the first experiment was to examine the real-time effects of tetanic SES on the maximal volitional level of force over repeated contractions of the triceps brachii muscle. To address this goal, seventeen subjects participated voluntarily in this study. Two features of the muscular force were assessed: The peak force (1) and the impulse (2). These two dependent variables were measured during 500 sec - including 50 maximal force productions of 4 sec each- in two randomized conditions of VOL and SES. When considering the 50 trials as a whole, exerted force was higher in the SES than in the VOL condition for both peak force and impulse (P<.05). Over time, peak force and impulse decreased consistently in VOL starting between the 20th and 30th trials whereas they were maintained in SES condition (P<.05).
The aim of the second experiment was to compare the effects of VOL and SES on the range of flexion recovery of the stiff metacarpophalangeal joint following operative repair of the ulnar collateral ligament of the thumb. To address this goal, eight patients participated voluntarily. Range of motion, oedema and pain were assessed before and after the two randomised conditions of VOL and SES.
- Conditions
- Thumb Joint Stiffness
- Being tested
- electrically induced muscle activation
- Keywords
- thumb, Ulnar collateral ligament, superimposed electrical stimulation, stiffness, adhesions
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrically induced muscle activationOther
30 Hz frequency, 200 µs pulse duration, and 40% duty cycle (4 sec on, 6 sec off)
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
Active range of motion was measured using a finger goniometer
Measured: 1sec after joint mobilization
Secondary outcomes (1)
muscle force
The peak force and the impulse were measured during 500 sec in two randomized conditions of voluntary muscle contraction and electrically induced muscle contraction
Measured: During the muscle contraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thumb Joint StiffnessStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Joseph Fourier
- Sponsor type
- University, hospital or other
- Investigators
- Vincent Nougier, PhD, Study director, Université Joseph Fourier - TIMC IMAG laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082432
- Sponsor's protocol ID
- SES 327
- Status last verified
- Feb 2010
- First submitted
- 1 Mar 2010
- Last updated
- 8 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bostock S, Morris MA. The range of motion of the MP joint of the thumb following operative repair of the ulnar collateral ligament. J Hand Surg Br. 1993 Dec;18(6):710-1. doi: 10.1016/0266-7681(93)90227-7.
PubMed 8308425
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superimposed Electrical Stimulation Real-time Effects on Repeated Muscle Contractions Enable to Increase Recovery From Thumb Joint Stiffness After Surgery of the Ulnar Collateral Ligament
- ClinicalTrials.gov ID
- NCT01082432
- Acronym / sponsor ID
- SES 327
- Conditions
- Thumb Joint Stiffness
- Keywords
- thumb, Ulnar collateral ligament, superimposed electrical stimulation, stiffness, adhesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Université Joseph FourierUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Mar 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.
Background
One of the potentially debilitative complications of operative repair and subsequent immobilization is stiffness that appears secondary to inflammation and adhesions. To prevent such a physical impairment, active joint mobilization has shown to be efficient. However, adhesions sometimes remain despite the therapy. Due to the viscoelastic nature of the biological tissues, if a technique can enable to extend the muscle ability to impose a maximal steady stress on adhesions, adhesion deformation should be greater and range of motion deficit should be reduced. Within that context, the purpose of the present study was to assess the real-time effects of superimposed electrical stimulation (SES) on maximal voluntary muscular contraction (VOL) over time and to assess SES effects on range of motion recovery in thumb stiff joint.
Methods and Findings
The aim of the first experiment was to examine the real-time effects of tetanic SES on the maximal volitional level of force over repeated contractions of the triceps brachii muscle. To address this goal, seventeen subjects participated voluntarily in this study. Two features of the muscular force were assessed: The peak force (1) and the impulse (2). These two dependent variables were measured during 500 sec - including 50 maximal force productions of 4 sec each- in two randomized conditions of VOL and SES. When considering the 50 trials as a whole, exerted force was higher in the SES than in the VOL condition for both peak force and impulse (P<.05). Over time, peak force and impulse decreased consistently in VOL starting between the 20th and 30th trials whereas they were maintained in SES condition (P<.05).
The aim of the second experiment was to compare the effects of VOL and SES on the range of flexion recovery of the stiff metacarpophalangeal joint following operative repair of the ulnar collateral ligament of the thumb. To address this goal, eight patients participated voluntarily. Range of motion, oedema and pain were assessed before and after the two randomised conditions of VOL and SES.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hand physical therapy center
Key inclusion criteria (2 listed)
- loss of range of flexion in the involved metacarpophalangeal joint of at least ten degrees when compared to the opposite thumb
- more than eight weeks post-surgery
Key exclusion criteria (1 listed)
- do not meet the inclusion criteria
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 |
|---|---|---|
| electrically induced muscle activation30 Hz frequency, 200 µs pulse duration, and 40% duty cycle (4 sec on, 6 sec off) | Other | – |
Primary outcome
range of motion
Time frame: 1sec after joint mobilization
Active range of motion was measured using a finger goniometer
1 secondary outcome
muscle force
Time frame: During the muscle contraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2010.
- Background: PubMed 8308425Bostock S, Morris MA. The range of motion of the MP joint of the thumb following operative repair of the ulnar collateral ligament. J Hand Surg Br. 1993 Dec;18(6):710-1. doi: 10.1016/0266-7681(93)90227-7.
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.
Vincent Nougier, PhD study director
Université Joseph Fourier - TIMC IMAG laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thumb Joint Stiffness, run by Université Joseph Fourier at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 8 Mar 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
range of motion (time frame: 1sec after joint mobilization). 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 NCT01082432, which also lists 1 linked publication.
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 8 Mar 2010.