Carpal Tunnel SyndromeNCT02706418
Clinical Massage Therapy as a Treatment for Carpal Tunnel Syndrome
A study testing Clinical Massage Therapy in people with Carpal Tunnel Syndrome, run by Jing Advanced Massage Training at 1 site in United Kingdom.
Trial summary
Once participants have been recruited, their grip strength shall be tested and they will all complete baseline questionnaires to assess functional status and symptom severity. Following the recruitment stage, participants will be asked to attend Medway Maritime Hospital once a week for four weeks, to receive the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Clinical Massage Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above.
- Pain paraesthesia and/or hypoesthesia in the hand, in the area innervated by the median nerve.
- Participants must have a clinical diagnosis of Carpal Tunnel Syndrome (CTS).
- Participant must be able to comply with the study procedures.
- Participant must have attended the Medway Maritime Hospital (Kent), for assessment of the present condition.
- Participant is willing and able to give informed consent for participation in the study.
- Participant must not be contra-indicated for the receipt of massage.
- Participants must be able to speak and read English fluently.
Who cannot join
- Participants who are receiving any additional treatment for their carpal tunnel pain that is not part of standard care (topical pain relief, bracing).
- Participants that have had any surgery on the anatomical sites relevant to the condition and/or treatment (neck, shoulder, arm, wrist, hand).
- Participants that have any suggestion of an additional condition related to carpal tunnel pain (i.e. previous trauma, pregnancy, etc).
- Planning to undertake any activities or lifestyle changes which may affect their levels of carpal tunnel pain (e.g. changing/ceasing occupation, alternative symptom therapy, adopting/ceasing a hobby).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY
About this study
Official title: A Standardised Massage Protocol as an Effective Treatment for Chronic Carpal Tunnel Syndrome
Once participants have been recruited, their grip strength shall be tested and they will all complete baseline questionnaires to assess functional status and symptom severity.
Following the recruitment stage, participants will be asked to attend Medway Maritime Hospital once a week for four weeks, to receive the massage protocol. At the first session participants shall be asked to rate their pain (NPRS), before receiving a massage treatment. This will be followed by instructions on how to perform self-massage, which they will be asked to complete daily over the four-week period, and record in a diary. At the remaining three sessions, participants shall just complete the NPRS prior to receiving the massage treatment.
After four weeks the group will be reassessed at the same Orthopaedic Clinic they attended prior to recruitment. They will be asked to complete a final pain score, record any changes in their condition, repeat the initial symptom questionnaire, and finally preform a grip strength test. The duration of four weeks was chosen as this is the time-frame within which the specific massage protocol advises a 'significant symptom improvement' should be seen.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Clinical Massage Therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Massage TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Clinical Massage Therapy | Other | Not described Receives: Procedure: Clinical Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing improvements in the symptoms of Carpal Tunnel Syndrome as assessed by the Boston Carpal Tunnel Questionnaire (BCTQ), change from baseline in the symptom severity scores at 4 weeks.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jing Advanced Massage Training
- Sponsor type
- University, hospital or other
- Collaborators
- Medway NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706418
- Sponsor's protocol ID
- CTS-01
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardised Massage Protocol as an Effective Treatment for Chronic Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02706418
- Acronym / sponsor ID
- CTS-01
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jing Advanced Massage TrainingUniversity, hospital or other
- Collaborators
- Medway NHS Foundation Trust
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Mar 2016 (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.
Once participants have been recruited, their grip strength shall be tested and they will all complete baseline questionnaires to assess functional status and symptom severity.
Following the recruitment stage, participants will be asked to attend Medway Maritime Hospital once a week for four weeks, to receive the massage protocol. At the first session participants shall be asked to rate their pain (NPRS), before receiving a massage treatment. This will be followed by instructions on how to perform self-massage, which they will be asked to complete daily over the four-week period, and record in a diary. At the remaining three sessions, participants shall just complete the NPRS prior to receiving the massage treatment.
After four weeks the group will be reassessed at the same Orthopaedic Clinic they attended prior to recruitment. They will be asked to complete a final pain score, record any changes in their condition, repeat the initial symptom questionnaire, and finally preform a grip strength test. The duration of four weeks was chosen as this is the time-frame within which the specific massage protocol advises a 'significant symptom improvement' should be seen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Massage Therapy | Other | Procedure: Clinical Massage Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or above.
- Pain paraesthesia and/or hypoesthesia in the hand, in the area innervated by the median nerve.
- Participants must have a clinical diagnosis of Carpal Tunnel Syndrome (CTS).
- Participant must be able to comply with the study procedures.
- Participant must have attended the Medway Maritime Hospital (Kent), for assessment of the present condition.
Key exclusion criteria (4 listed)
- Participants who are receiving any additional treatment for their carpal tunnel pain that is not part of standard care (topical pain relief, bracing).
- Participants that have had any surgery on the anatomical sites relevant to the condition and/or treatment (neck, shoulder, arm, wrist, hand).
- Participants that have any suggestion of an additional condition related to carpal tunnel pain (i.e. previous trauma, pregnancy, etc).
- Planning to undertake any activities or lifestyle changes which may affect their levels of carpal tunnel pain (e.g. changing/ceasing occupation, alternative symptom therapy, adopting/ceasing a hobby).
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 |
|---|---|---|
| Clinical Massage Therapy | Procedure or surgery | Clinical Massage Therapy |
Primary outcome
Number of participants experiencing improvements in the symptoms of Carpal Tunnel Syndrome as assessed by the Boston Carpal Tunnel Questionnaire (BCTQ), change from baseline in the symptom severity scores at 4 weeks.
Time frame: 4 weeks.
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 28 Feb 2018.
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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.
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 Clinical Massage Therapy in people with Carpal Tunnel Syndrome, run by Jing Advanced Massage Training 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 8 inclusion and 4 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 28 Feb 2018. 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 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?
Number of participants experiencing improvements in the symptoms of Carpal Tunnel Syndrome as assessed by the Boston Carpal Tunnel Questionnaire (BCTQ), change from baseline in the symptom severity scores at 4 weeks. (time frame: 4 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 28 Feb 2018.