Physiotherapy for Non-specific Neck Pain in Working Age Persons

January 10, 2024 updated by: Vilma Dudoniene, Lithuanian Sports University

Comparative Effect of Post Isometric Relaxation and Self-stretching on Non-specific Neck Pain in Working Age Persons

The goal of this clinical trial is to learn about the effects of two different physiotherapy methods on non-specific neck pain in working age individuals. The main questions it aims to answer are:

  • What is the effect of self stretching exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals?
  • What is the effect of post-isometric relaxation exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals?
  • Is any of the applied interventions (self-stretching or post-isometric relaxation exercise) superior to each other?

Participants will:

  • be evaluated by an experienced physiotherapist who will perform the interview and physical examination. Interview includes questions about the age, sex, work profile, pain intensity and duration, and other complaints. Physiotherapy examination includes a range of motion measurement, hand grip muscle strength and functional disability index evaluation.
  • Two different interventions will be prescribed to the randomly assigned study participants: post-isometric relaxation and self-stretching. Duration of interventions for both groups is 4 weeks (3 times per week, 12 sessions). Duration of one session - 45 min.

Study Overview

Detailed Description

The goal of this clinical trial is to learn about the effects of two different physiotherapy methods on non-specific neck pain in working age individuals. The main questions it aims to answer are:

What is the effect of self stretching exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals? What is the effect of post-isometric relaxation exercise on non-specific neck pain, functional disability, range of motion of the cervical spine and hand muscle strength in working age individuals? Is any of the applied interventions (self-stretching or post-isometric relaxation exercise) superior to each other?

Participants will:

be evaluated by an experienced physiotherapist who will perform the interview and physical examination. Interview includes questions about the age, sex, work profile, pain intensity and duration, and other complaints. Physiotherapy examination includes a range of motion measurement, hand grip muscle strength and functional disability index evaluation.

Two different interventions will be prescribed to the randomly assigned study participants: post-isometric relaxation and self-stretching. Duration of interventions for both groups is 4 weeks (3 times per week, 12 sessions). Duration of one session - 45 min.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kaunas, Lithuania
        • Lithuanian Sports University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • current neck pain,
  • neck pain duration for at least 12 weeks,
  • admission through outpatient clinic in Lithuania.

Exclusion Criteria:

  • neurological disorders related to neck pain,
  • red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch),
  • previous neck surgery,
  • low back pain,
  • medications used for pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-stretching exercise group
Static neck muscle self-stretching exercises were performed for 30 min. after the TENS procedure. Every muscle in the neck region (head rotator cuff, neck stair muscles, upper part of the trapezius muscle, scapula levator muscle, semiscapular neck muscle, upper oblique head muscle, girdle head and neck muscles, and deep anterior neck flexor muscles) were stretched 3 times for 30 seconds per muscle group. While performing exercises, the subjects applied resistance with their hands. All exercises were performed without causing pain.
Static neck muscle self-stretching exercises were performed for 30 min. after the TENS procedure. Every muscle in the neck region (head rotator cuff, neck stair muscles, upper part of the trapezius muscle, scapula levator muscle, semiscapular neck muscle, upper oblique head muscle, girdle head and neck muscles, and deep anterior neck flexor muscles) were stretched 3 times for 30 seconds per muscle group. While performing exercises, the subjects applied resistance with their hands. All exercises were performed without causing pain.
Experimental: Post-isometric relaxation exercise group
The investigators used one of the autogenic inhibition techniques - post-isometric relaxation (PIR), known as the muscle "contraction-relaxation" technique, during which, the subject is lying on his back, he is asked to press his head in the specified direction (50% of the subject's maximum pressure force). to the resistance provided by the therapist. During the press, resistance was provided for 10 seconds and followed by a passive stretch of the muscle in the opposite direction of movement. A total of 5 repetitions are performed for each muscle with a 5-second break. All movements are performed without causing pain of more than moderate intensity.
The investigators used one of the autogenic inhibition techniques - post-isometric relaxation (PIR), known as the muscle "contraction-relaxation" technique, during which, the subject is lying on his back, he is asked to press his head in the specified direction (50% of the subject's maximum pressure force). to the resistance provided by the therapist. During the press, resistance was provided for 10 seconds and followed by a passive stretch of the muscle in the opposite direction of movement. A total of 5 repetitions are performed for each muscle with a 5-second break. All movements are performed without causing pain of more than moderate intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Change from Baseline Quality of Life at 4 weeks
Neck pain intensity was assessed using a visual analogue scale (VAS) on a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the VAS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.
Change from Baseline Quality of Life at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical spine range of motion
Time Frame: Change from Baseline Quality of Life at 4 weeks
ROM was measured using bubble inclinometer, which was placed on the top of the patient's head, along the sagittal plane to measure neck flexion and extension, when the patient was in sitting position. Side bending was measured from the same starting position just as the inclinometer was placed in the frontal plane on the top of the patient's head. Rotations to the left and right were taken from the supine position with an inclinometer placed on the forehead. The inclinometer's reading at the starting position was 0. The readings of ROM were taken when the end point of movement was reached. In our study, three repetitions were performed in each direction, and the average value was taken for analysis.
Change from Baseline Quality of Life at 4 weeks
Hand grip strength
Time Frame: Change from Baseline Quality of Life at 4 weeks
Hand grip strength was measured using a hand dynamometer (Saehan SH5001, Germany). Grip strength of the dominant and non-dominant hand was measured when seated with the shoulder neutrally rotated and adducted, the elbow flexed at 90°, and the wrist and forearm in a neutral position. The maximum grip strength was measured in kilograms (kg). Three measurements were taken with 60 s rest between each trial and the average result was recorded.
Change from Baseline Quality of Life at 4 weeks
The Neck Disability Index
Time Frame: Change from Baseline Quality of Life at 4 weeks
The Neck Disability Index (NDI) questionnaire consists of 10 items. Each item on the scale is scored from 0 to 5, where all the scores are added to total points and interpreted as percentages i.e., 0 point or 0% means no activity limitation, and 50 points or 100% means complete activity limitation. The NDI is a reliable and valid questionnaire in neck pain patients with intraclass correlation ranges between 0.50-0.98. Patients scored between 0-4 points (0-8%) are considered with no disability, between 5-14 points (10-28%) with mild disability, 15-24 points (30-48%) - moderate disability, 25-34 points (50- 64%) - severe disability, and 35-50 points (70-100%) - complete disability
Change from Baseline Quality of Life at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vilma Dudoniene, Lithuanian Sports University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LithuanianSportsU-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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