Protocol summary
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Study aim
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The effects of conventional physical therapy with and without neck manual therapy on clinical outcomes in people with carpal tunnel syndrome
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Design
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Randomized control trial with 2 group of control and treatment design of 40 patients, double-blind, with a parallel group.
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Settings and conduct
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Patients are randomly assigned to either intervention or treatment groups at Golestan hospital in Ahvaz. In this study, patients and assessors are blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Tingling, numbness, burning or pain in at least 2 of digits 1, 2 or 3.
Ages range between 18 to 60.
Positive result Phalen or Tinnel sign or Carpal compression test.
Existance CTS symptoms for greater than twelve weeks.
Pain intensity at least a 4/10 on a Visual Analog Scale over the past 24 h.
Electrodiagnostic findings indicate mild to moderate damage to the median nerve.
Exclusion criteria:
Any sensory or motor deficit in either the ulnar or radial nerve.
History of surgery or injection in the wrist area.
Presence of systemic diseases such as rheumatoid arthritis, fibromyalgia, diabetes mellitus , hyperthyroidism or hypothyroidism
The presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy.
Pregnancy.
History of neck, shoulder or upper extremity trauma.
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Intervention groups
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Intervention group: Combined conventional physiotherapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy and neck manual therapies.
Control group: Conventional physiotherapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy
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Main outcome variables
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Pain, upper limb level of function, symptoms and functional status of patients, median sensory nerve conduction velocity, median nerve motor distal latency
General information
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Reason for update
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Due to the continuation of the COVID-19 pandemic condition and the lack of patient referrals and patient follow-up, the end date was increased.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201201049565N1
Registration date:
2020-12-15, 1399/09/25
Registration timing:
prospective
Last update:
2022-04-18, 1401/01/29
Update count:
2
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Registration date
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2020-12-15, 1399/09/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-20, 1399/09/30
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Expected recruitment end date
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2021-08-22, 1400/05/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of conventional physical therapy with and without neck manual therapy on clinical outcomes in people with carpal tunnel syndrome
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Public title
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The effects of neck manual therapy on the carpal tunnel syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Tingling, numbness, burning or pain in at least 2 of digits 1, 2 or 3
Ages 18-60 years
Positive Phalen sign or Tinnel sign over the carpal tunnel or carpal compression test
CTS symptoms present for greater than twelve weeks
Pain intensity at least a 4/10 on a Visual Analog Scale scale over the past 24 h
Electrodiagnostic findings indicate mild to moderate damage to the median nerve
Exclusion criteria:
Any sensory or motor deficit in either the ulnar or radial nerve
History of surgery or injection in the wrist area
Presence of systemic diseases such as rheumatoid arthritis, fibromyalgia
A history of systemic disease associated with carpal tunnel syndrome (such as diabetes mellitus or hyperthyroidism or hypothyroidism)
The presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy
Pregnancy
History of neck, shoulder or upper extremity trauma
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals who met the inclusion criteria were randomly
allocated to Group A (conventional physiotherapy) or Group B (combination of conventional physiotherapy treatments with neck manual therapy) using Block randomization (size: 4 and 6) prepare by an independent statistician with no clinical involvement in the trial. The allocation will be concealed in opaque, sealed envelope. A research assistant opens the envelopes to reveal group allocation before starting the intervention
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This is a double-blind clinical trial in which patients are evaluated by another physiotherapist who is unaware of assigning individuals to groups. Patients and data analysts will also be unaware of group assignments.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-01, 1399/09/11
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Ethics committee reference number
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IR.AJUMS.REC.1399.727
Health conditions studied
1
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Description of health condition studied
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Carpal Tunnel Syndrome
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ICD-10 code
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G56.0
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ICD-10 code description
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Carpal tunnel syndrome
Primary outcomes
1
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Description
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pain
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Timepoint
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One day before first session of treatment, two or three days after end of treatment
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Method of measurement
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Visual Analog Scale
2
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Description
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Upper limb level of function
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Timepoint
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One day before first session of treatment, two or three days after end of treatment
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Method of measurement
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Disabilities of the arm, shoulder and hand (DASH) questionnaire
3
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Description
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Symptoms and functional status of patients
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Timepoint
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One day before first session of treatment, two or three days after end of treatment
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Method of measurement
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Boston Carpal Tunnel(BCTQ) Questionnaire
4
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Description
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Median sensory nerve conduction velocity
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Timepoint
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One day before first session of treatment, two or three days after end of treatment
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Method of measurement
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Tru trace 4 EMG system DEYMED electromyography device
5
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Description
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Median nerve motor distal latency
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Timepoint
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One day before first session of treatment, two or three days after end of treatment
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Method of measurement
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Tru trace 4 EMG system DEYMED electromyography device
Intervention groups
1
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Description
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Intervention group: Combined conventional physical therapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy and neck manual therapies.
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Category
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Rehabilitation
2
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Description
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Control group: Conventional physical therapy including wrist splints, electrical stimulation, phonophoresis
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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The person's information will be confidential and the results will be as collective statistics
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists.
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When the data will become available and for how long
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If the journal has requested access to the data at any time, the data will be provided.
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To whom data/document is available
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Journal editors and Reviewers
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Under which criteria data/document could be used
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Sometimes for re-analysis or for use in meta-analysis studies
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From where data/document is obtainable
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Project manager
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What processes are involved for a request to access data/document
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It should be send email to project manager and after reviewing the reason for requesting the data, they will be send
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Comments
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