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NCT Number: NCT04638062

Effect of Post Isometric Relaxation Versus Myofascial Release Therapy in the Management of Non Specific Neck Pain

Non-specific neck pain (NS-NP) is the most prevailing musculoskeletal disorder (MSK) which has large socio-economic burden worldwide. It is associated with poor posture and neck strain which may lead to pain and restricted mobility. Post isometric relaxation a form of Muscle energy technique, that works on the principles of restoring biomechanics, reducing the movement restriction and pain. Myofascial release therapy will improve muscle immobility and pain by improving blood circulation lymphatic drainage and relaxing the contracted muscles. The aim of this study is to determine the effect of Post-isometric relaxation Versus Myofascial release therapy on pain, range of motion, disability and quality of life in the management of non-specific neck pain.

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Key information

Conditions

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

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow university of health sciences & Institute of physical medicine and rehabilitation

Karachi, Sindh, 74200, Pakistan

About this study

A randomized control trial will be conducted at IPMR (Institute of Physical Medicine and Rehabilitation) on 60 patients with non-specific neck pain with age group between 25-40 years. Initial screening of the patients will be carried out by referring physiatrist. Patients who fulfils inclusion criteria will be randomly allocated to either group by computer generated random sampling after taking written informed consent. All the patients will be evaluated using Visual analogue scale for pain, Neck disability index for functional status and disability, Universal goniometer for cervical range of motion and WHO BREF for quality of life on 1st and 6th sessions. Group 1 will receive Post isometric relaxation for Upper trapezius and levator scapulae along with Cryotherapy and strengthening exercises . Group 2 will receive myofascial release therapy for Upper Trapezius and Levator scapulae muscles along with cryotherapy and strengthening exercises. Data will be analyzed using the SPSS version 21. Baseline reading will be taken for further comparison at the end of treatment. Baseline variables are Pain, ROM, Functional disability and Qol. For within group analysis, paired sample t test will be used. For intergroup independent sample t test will be used. P value less than 0.05 will be set as threshold to detect statistical significance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-specific neck pain for 2-6 weeks.
  • Unilateral neck pain
  • Patients' age group between 25 - 40.
  • On VAS scale pain intensity >4.

Exclusion criteria

  • Cervicogenic headache.
  • Tumor of cervical spine.
  • Whiplash injury.
  • Cervical Fractures
  • Normal ROM of cervical spine.

Treatment and study plan

1.Post Isometric Relaxation

Other

For Upper Trapezius In supine position Neck flexion, contra-lateral full side bending followed by slight ipsilateral rotation will be provided towards the side being treated. while asking the patient to shrug the stabilized shoulder and contraction will be maintained for 7- 10s. Repeating it 3-5 times.

For Levator Scapulae Step One In supine position while lifting the patients neck in full flexion, lateral flexion and rotation with 7-10s isometric contraction away from side to be treated will be provided.

Step Two The patient will be instructed to take head backwards to the table while at the same time asking the patient to slightly shrug the shoulder and resistance will be provided. Repeating it 3-5 times.

2.Neck isometric strengthening exercises Intensity 5 reps Frequency at 1st week one set and second week will progress to 2 sets

3.Cryotherapy will be placed on cervical region for 10 min after the treatment.

1.Myofascial Release therapy

Other

For Upper Trapezius In sitting position Myofascial Release of Trapezius will be performed unilaterally with soft fist or elbow sinking and then taking up the line of tension from mid belly of Trapezius, to the acromion process, while the patient drops the head forward and will slowly rotate the head from side to side. While providing the resistance to contralateral side of rotation. Repeating for 2-3 times.

For Levator Scapulae In sitting position applying same unilateral muscle release as Trapezius, but the line of tension will be to the inferior border of Scapulae slightly laterally and will ask the patient to drop the head forward to increase resistance on Levator muscle. Repeating it 2-3 times

2.Neck isometric strengthening exercises Intensity 5 reps Frequency at 1st week one set and second week will progress to 2 sets

3.Cryotherapy will be placed on cervical region for 10 min after the treatment.

Primary outcomes

  1. Neck Disability Index (NDI)

    Time frame: baseline and post intervention 2 weeks

    NDI is a condition specific or patient completed questionnaire comprising of 10 items to evaluate pain, and functional status which is mostly used for reporting neck pain. Each item on scale is scored from 0-5, 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.

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: baseline and 2 weeks

    It is 10cm or 10nm line psychometric response scale to measure pain. Aggregate score ranges from 0-10. Score 0-4 means mild pain, 4-7 means moderate pain and 7- 10 means severe pain

  2. Range of Motion

    Time frame: baseline and 2 weeks

    The universal goniometer (UG) is a measuring tool commonly used in clinics, to measure active cervical range of motion (ACROM), UG will be used to measure cervical ranges in all directions i.e. flexion, extension, lateral flexion and rotation. To measure cervical flexion and extension the UG axis will be placed over the external auditory meatus and will asked the patient will be asked to flex and extend the head, for lateral flexion over centre of sternal notch and for the cervical rotation over the centre of subject's head

  3. WHO Quality of life-BREF (WHOQOL BREF)

    Time frame: baseline and 2 weeks

    The WHOQOL-BREF is an instrument which is used to assess psychometric properties. Consisting of 26 questions related to the following 4 domains: physical, psychological health, social relationship and environment. Each item is rated on 5-point scoring scale where each score is transferred between 0 and 100.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Effect of Post Isometric Relaxation Versus Myofascial Release Therapy on Pain, Functional Disability and QoL in the Management of Non Specific Neck Pain: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Jul 29, 2022

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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