Wrist StrainNCT03839901
Rehabilitation Programmes for Scapholunate Instability
A study testing Home exercise program in people with Wrist Strain and Wrist Sprain, run by University of Bradford at 1 site in United Kingdom.
Trial summary
Two different exercises approaches were tested in patients with Scapho-Lunate (SL) instability; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Wrist Strain, Wrist Sprain, Scaphoid-Lunate Instability
- What is being tested?
- Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2017to 1 Aug 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages eighteen to sixty,
- wrist pain,
- confirmed scapholunate ligament disruption on MRA or XR (partial or full),
- referred from orthopaedic wrist specialist,
- for conservative management,
- consent to trial.
Who cannot join
- Under eighteen or over sixty years,
- previous fracture,
- degenerative changes in the wrist,
- previous surgery,
- complex regional pain syndrome or diagnosis of rheumatological conditions,
- no wrist injection in preceding twelve months or other wrist conditions.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ
About this study
Official title: A Pilot Study to Investigate Two Different Physiotherapy Rehabilitation Programmes, to Treat the Conservatively Managed Scapholunate Instability.
Two different exercises approaches were tested in patients with Scapho-Lunate (SL) instability; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.
Read the detailed description
Scapho-Lunate (SL) instability is the most common form of wrist instability, but is complex to diagnose and is often missed entirely. The natural progression of SL instability has been suggested to lead to osteoarthritis. The management of SL instability can be broadly divided into conservative and surgical, with the former being the first option taken by most medical professionals, which primarily involves physiotherapy. The evidence base for physiotherapy management of SL instability is limited; however cadaver research has identified loading some of the wrist tendons may stabilise the scaphoid and lunate.There is currently no research as to whether this clinically makes any difference to the patients symptoms, or how to do it. This research therefore aimed to test the protocol and methods, and act as a platform for larger studies, to investigate this.
Two different exercises approaches were tested; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.
- Conditions
- Wrist Strain, Wrist Sprain, Scaphoid-Lunate Instability
- Being tested
- Home exercise program
- Keywords
- Scaphoid-Lunate, instability, wrist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise programOther
Home exercise programme with participants followed up at week 1, 4, 6 and 8.
| Study group | Role | What they receive |
|---|---|---|
| isometric training programme | Experimental | 'Home exercise programme' consisting of isometric exercises with participants followed up at week 1, 4, 6 and 8. Receives: Other: Home exercise program |
| isotonic training programme | Experimental | 'Home exercise programme' consisting of isotonic exercises with participants followed up at week 1, 4, 6 and 8. Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength using E-link dynamometer
change of grip strength from baseline change of 20% in kg considered signifcant
Measured: assessed at 0, 4 and 8 weeks
Secondary outcomes (2)
numerical rating scale
Pain scored on a numerical rating scale 0 (no pain) -10 (unbearable pain) Minimally Clinical Important Difference of 20mm
Measured: assessed at 0, 4 and 8 weeks
Patient Rated Wrist Evaluation
Used Patient Rated Wrist Evaluation PRWE questionnaire (A score of 100 represents the worst functional score, whereas 0 represents no disability) with Minimally Clinical Important Difference of 14 points
Measured: assessed at 0, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Aug 2017
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Why it stopped: There were insufficient numbers recruited before the end of the student project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist StrainStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bradford
- Sponsor type
- University, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839901
- Sponsor's protocol ID
- IRAS 218328
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Two Different Physiotherapy Rehabilitation Programmes, to Treat the Conservatively Managed Scapholunate Instability.
- ClinicalTrials.gov ID
- NCT03839901
- Acronym / sponsor ID
- IRAS 218328
- Conditions
- Wrist Strain, Wrist Sprain, Scaphoid-Lunate Instability
- Keywords
- Scaphoid-Lunate, instability, wrist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were insufficient numbers recruited before the end of the student project
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of BradfordUniversity, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- 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.
Two different exercises approaches were tested in patients with Scapho-Lunate (SL) instability; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.
Detailed description
Scapho-Lunate (SL) instability is the most common form of wrist instability, but is complex to diagnose and is often missed entirely. The natural progression of SL instability has been suggested to lead to osteoarthritis. The management of SL instability can be broadly divided into conservative and surgical, with the former being the first option taken by most medical professionals, which primarily involves physiotherapy. The evidence base for physiotherapy management of SL instability is limited; however cadaver research has identified loading some of the wrist tendons may stabilise the scaphoid and lunate.There is currently no research as to whether this clinically makes any difference to the patients symptoms, or how to do it. This research therefore aimed to test the protocol and methods, and act as a platform for larger studies, to investigate this.
Two different exercises approaches were tested; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isometric training programme | Experimental | Other: Home exercise program'Home exercise programme' consisting of isometric exercises with participants followed up at week 1, 4, 6 and 8. |
| isotonic training programme | Experimental | Other: Home exercise program'Home exercise programme' consisting of isotonic exercises with participants followed up at week 1, 4, 6 and 8. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages eighteen to sixty,
- wrist pain,
- confirmed scapholunate ligament disruption on MRA or XR (partial or full),
- referred from orthopaedic wrist specialist,
- for conservative management,
Key exclusion criteria (6 listed)
- Under eighteen or over sixty years,
- previous fracture,
- degenerative changes in the wrist,
- previous surgery,
- complex regional pain syndrome or diagnosis of rheumatological conditions,
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 |
|---|---|---|
| Home exercise programHome exercise programme with participants followed up at week 1, 4, 6 and 8. | Other | isometric training programme, isotonic training programme |
Primary outcome
Grip strength using E-link dynamometer
Time frame: assessed at 0, 4 and 8 weeks
change of grip strength from baseline change of 20% in kg considered signifcant
2 secondary outcomes
numerical rating scale
Time frame: assessed at 0, 4 and 8 weeks
Patient Rated Wrist Evaluation
Time frame: assessed at 0, 4 and 8 weeks
Results and safety
The study was stopped early (reason given: There were insufficient numbers recruited before the end of the student project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise program in people with Wrist Strain and Wrist Sprain, run by University of Bradford at 1 site in United Kingdom.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Feb 2019. 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 United Kingdom. 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 was stopped early (reason given: There were insufficient numbers recruited before the end of the student project). 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?
Grip strength using E-link dynamometer (time frame: assessed at 0, 4 and 8 weeks). 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 15 Feb 2019.