NCT02706418

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

February 26, 2016

Last Update Submit

February 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks.

Study Arms (1)

Clinical Massage Therapy

OTHER
Procedure: Clinical Massage Therapy

Interventions

Clinical Massage Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medway Maritime Hospital

Gillingham, Kent, ME7 5NY, United Kingdom

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 11, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations