Physiotherapy for Non-specific Neck Pain in Working Age Persons

NCT06200064 | Completed

• 1 other identifier: LithuanianSportsU-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain; Non-specific Neck Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  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 Outcomes (3)

• Cervical spine range of motion

  Change from Baseline Quality of Life at 4 weeks

• Hand grip strength

  Change from Baseline Quality of Life at 4 weeks

• The Neck Disability Index

  Change from Baseline Quality of Life at 4 weeks

Study Arms (2)

Self-stretching exercise group

EXPERIMENTAL

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.

Other: Self-stretching exercise group

Post-isometric relaxation exercise group

EXPERIMENTAL

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.

Other: Post-isometric relaxation exercise group

Interventions

Self-stretching exercise group OTHER

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.

Self-stretching exercise group

Post-isometric relaxation exercise group OTHER

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.

Post-isometric relaxation exercise group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian Sports University: lead

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vilma Dudoniene

  Lithuanian Sports University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes were measured by separate physiotherapist, who did not provide prescribed intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lithuanian Sports University

Model Details: This study is a four week, single blinded randomized controlled trial with pre-post design comparing self-stretching exercise group with post-isometric relaxation exercise group.

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: October 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 15, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)