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Completed

NCT Number: NCT03840473

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

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.

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Key information

Conditions

Myofascial Trigger Point Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Myofascial Pain Syndromes Neck Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–38 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Research Chair

Riyadh, 11433, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Muscle tenderness

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

    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.

  2. Neck pain intensity

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

    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.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • Shah Physiotherapy Center, Delhi, India

Registry information

Official study title

Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Patients With Upper Trapezius Myofascial Trigger Points

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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