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

NCT03840473 | Completed DMC

• 1 other identifier: RRC-2017-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Trigger Point Pain

Keywords

Neck pain; Upper trapezius muscle; Myofascial trigger points; Muscle tenderness; Pain pressure threshold

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up

• 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.

  Change from baseline VAS scores at day 1 post intervention and after 2-weeks follow-up

Study Arms (3)

MET+ICT+Conventional intervention

EXPERIMENTAL

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).

Behavioral: MET; Behavioral: ICT; Behavioral: Conventional Intervention

MET+Conventional Intervention

EXPERIMENTAL

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).

Behavioral: MET; Behavioral: Conventional Intervention

Conventional Intervention

ACTIVE COMPARATOR

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.

Behavioral: Conventional Intervention

Interventions

MET BEHAVIORAL

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.

MET+Conventional Intervention; MET+ICT+Conventional intervention

ICT BEHAVIORAL

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.

MET+ICT+Conventional intervention

Conventional Intervention BEHAVIORAL

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.

Conventional Intervention; MET+Conventional Intervention; MET+ICT+Conventional intervention

Eligibility Criteria

• Age: 19 Years - 38 Years
• Gender Eligibility Details: Male only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead
• Shah Physiotherapy Center, Delhi, India: collaborator

Study Sites (1)

Rehabilitation Research Chair

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Neck Pain; Myalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Study Officials

• Amir Iqbal, MPT

  Rehabilitation Research Chair

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: August 11, 2017
• Primary Completion: December 19, 2017
• Study Completion: February 15, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

SA (1)