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Efficacy of Combination Therapies on Neck Pain & Muscle Tenderness in Patients With Upper Trapezius MTrPs

Primary Purpose

Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
MET
ICT
Conventional Intervention
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring Neck pain, Upper trapezius muscle, Myofascial trigger points, Muscle tenderness, Pain pressure threshold

Eligibility Criteria

19 Years - 38 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male subject diagnosed with non-specific neck pain and muscle tenderness over the upper trapezius muscle due to an active MTrP
  • Age19-38 years
  • Presence of a maximum of 1-2active MTrPs in a unilateral upper trapezius muscle The number of TrPs in upper trapezius is not limited to two; it may be one or may be more than two (satellite TrPs) also. However, due to time constraints of the study sessions allowed for treatment of up to 2 active MTrPs only.

Exclusion Criteria:

  • Diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria;
  • Had active MTrPs in the bilateral upper trapezius muscles
  • Had a history of whiplash injury or cervical spine surgery
  • Were diagnosed with cervical radiculopathy or myelopathy determined by their primary health care physician
  • Had accepted myofascial pain therapy within the 1 month before the study
  • Showed poor cooperation.

Sites / Locations

  • Rehabilitation Research Chair

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

MET+ICT+Conventional intervention

MET+Conventional Intervention

Conventional Intervention

Arm Description

Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).

Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).

Received hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) only.

Outcomes

Primary Outcome Measures

Muscle tenderness
A pressure algometer used to assess the muscle tenderness by measuring Pressure Pain Threshold (PPT) level of MTrPs as suggested by Fischer. The trigger point with the lowest PPT value was chosen as a primary trigger point. The subjects were instructed to indicate the sensation of pressure they felt from changing from one of pressure to one of pain by saying "there"/ "yes." Three repeated measurements were obtained by the same assistant, and the mean was used in the analysis. At least a 1-minute gap was added between the two repeated measurements as recommended by Fischer.
Neck pain intensity
Visual analogue scale (VAS) used to measure neck pain intensity. VAS is a subjective rating scale marked with 0 (No pain) and 10 (extremely unbearable pain) on its either end. An application of 2.5 kg/cm-square of pressure was applied at the rate of 1 kg/cm-square by the physiotherapist while the subjects were stated to rate their pain on the visual analog scale (VAS) to evaluate local pain evoked by the application of that amount of pressure.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2019
Last Updated
February 12, 2019
Sponsor
King Saud University
Collaborators
Shah Physiotherapy Center, Delhi, India
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1. Study Identification

Unique Protocol Identification Number
NCT03840473
Brief Title
Efficacy of Combination Therapies on Neck Pain & Muscle Tenderness in Patients With Upper Trapezius MTrPs
Official Title
Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Patients With Upper Trapezius Myofascial Trigger Points
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
Collaborators
Shah Physiotherapy Center, Delhi, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Myofascial pain syndrome thought to be the main cause of neck pain and shoulder muscle tenderness in the working population is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in patients with upper trapezius Myofascial Trigger points.
Detailed Description
Purpose: Myofascial pain syndrome, thought to be the main cause of neck pain and shoulder muscle tenderness in the working population, is characterized by myofascial trigger points (MTrPs). This study aimed to examine the immediate and short-term effect of the combination of two therapeutic techniques for improving neck pain and muscle tenderness in male patients with upper trapezius active MTrPs. Methods: This was a pretest-posttest single-blinded randomized controlled trial. Sixty male subjects with mechanical neck pain due to upper trapezius active MTrPs were recruited and randomly allocated into group A, which received muscle energy technique (MET) and ischemic compression technique (ICT)along with conventional intervention; group B, which received all the interventions of group A except ICT; and group C, which received conventional treatment only. Baseline (Pr), immediate post-intervention (Po), and 2-week follow-up (Fo) measurements were made for all variables. Pain intensity and pressure pain threshold (PPT)were assessed by a visual analog scale (VAS) and pressure threshold meter, respectively. All three groups received their defined intervention plans only. Repeated-measures analysis of variance was used to perform intra- inter-group analyses. Cohen's d test was used to assess the effect size of the applied interventions within the groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
Keywords
Neck pain, Upper trapezius muscle, Myofascial trigger points, Muscle tenderness, Pain pressure threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MET+ICT+Conventional intervention
Arm Type
Experimental
Arm Description
Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).
Arm Title
MET+Conventional Intervention
Arm Type
Experimental
Arm Description
Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).
Arm Title
Conventional Intervention
Arm Type
Active Comparator
Arm Description
Received hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) only.
Intervention Type
Behavioral
Intervention Name(s)
MET
Intervention Description
The patient was in a supine position with the cervical spine in the opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were in a lengthened position.19 The moderate isometric contraction (approximately 75% of maximal) of the upper trapezius muscles was elicited for a period of 5 seconds followed by 3 seconds of relaxation while reaching the new barrier. The technique was repeated four times in each session.
Intervention Type
Behavioral
Intervention Name(s)
ICT
Intervention Description
The patient lying in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position.18,22 The physiotherapist applied gradually increasing pressure to the MTrPs until the subject perceived the first noticeable pain. At that moment, the pressure was maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure was increased until the discomfort appeared again. This process was maintained for 90 seconds.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Intervention
Intervention Description
Hot packs (75°C) for 20 minutes and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions). Active stretching exercises were done by all the participants under the supervision of the physical therapist. This approach was standardized for all participants.
Primary Outcome Measure Information:
Title
Muscle tenderness
Description
A pressure algometer used to assess the muscle tenderness by measuring Pressure Pain Threshold (PPT) level of MTrPs as suggested by Fischer. The trigger point with the lowest PPT value was chosen as a primary trigger point. The subjects were instructed to indicate the sensation of pressure they felt from changing from one of pressure to one of pain by saying "there"/ "yes." Three repeated measurements were obtained by the same assistant, and the mean was used in the analysis. At least a 1-minute gap was added between the two repeated measurements as recommended by Fischer.
Time Frame
Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up
Title
Neck pain intensity
Description
Visual analogue scale (VAS) used to measure neck pain intensity. VAS is a subjective rating scale marked with 0 (No pain) and 10 (extremely unbearable pain) on its either end. An application of 2.5 kg/cm-square of pressure was applied at the rate of 1 kg/cm-square by the physiotherapist while the subjects were stated to rate their pain on the visual analog scale (VAS) to evaluate local pain evoked by the application of that amount of pressure.
Time Frame
Change from baseline VAS scores at day 1 post intervention and after 2-weeks follow-up

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male only
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male subject diagnosed with non-specific neck pain and muscle tenderness over the upper trapezius muscle due to an active MTrP Age19-38 years Presence of a maximum of 1-2active MTrPs in a unilateral upper trapezius muscle The number of TrPs in upper trapezius is not limited to two; it may be one or may be more than two (satellite TrPs) also. However, due to time constraints of the study sessions allowed for treatment of up to 2 active MTrPs only. Exclusion Criteria: Diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria; Had active MTrPs in the bilateral upper trapezius muscles Had a history of whiplash injury or cervical spine surgery Were diagnosed with cervical radiculopathy or myelopathy determined by their primary health care physician Had accepted myofascial pain therapy within the 1 month before the study Showed poor cooperation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Iqbal, MPT
Organizational Affiliation
Rehabilitation Research Chair
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Research Chair
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Combination Therapies on Neck Pain & Muscle Tenderness in Patients With Upper Trapezius MTrPs

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