NCT05812625

Brief Summary

The goal of this clinical trial is to examine the effectiveness of Myo-kinetic stretching exercises versus post-isometric relaxation exercise in patients with cervical radiculopathy. Convenient sampling technique will be used to enroll the patients. Patients will be screened on the basis of pre formulated eligibility criteria. Written Consent will be taken from each patient for participation in the trial. The calculated Sample size of this study will be 68 calculated through Epitool. Group A will receive conservative baseline treatment consisted of hot pack therapy for 10 minutes and traction for 8 minutes. Myo-kinetic stretching exercises and group B will receive conservative baseline treatment and post-isometric relaxation exercise. The assessment of patients will be done at baseline, 4th and 8th week. The outcomes from patients will be calculated by using Numeric Pain Rating Scale (NPRS), Goniometer and Neck Disability Index. The comparison between pre-treatment and post-treatment data will be done after 8th week. Data will be analyzed through SPSS 25.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 31, 2023

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cervical Pain

    Cervical Pain will be measured by Numeric Pain Rating Scale

    8 weeks

  • Neck Disability

    Neck disability will be measured by Neck Disability Index

    8 weeks

  • Cervical Range of motion

    Cervical Range of motion will be measured by Goniometer

    8 weeks

Study Arms (2)

Interventional Group A

EXPERIMENTAL

• Group A will receive conservative baseline treatment consisted of hot pack therapy for 10 minutes and traction for 8 minutes with Myokinetic stretching technique. Subject will be in supine lying on the plinth and the head will be placed at the edge of the plinth by the therapist. Then with one hand the therapist held the neck in cervical lateral flexion to the opposite side so as to achieve the stretching of the trapezius muscle. Myofascial release by applying sustained finger pressure for 5-10 s on the involved trapezius was given. A gentle myofascial stretching force was applied to take up slack and sustained until a release occurred .The MST protocol comprised of three sets of 4 stretches with 5 seconds rest period between the stretches. Treatment will be provided twice a week for 8 weeks.

Other: Myokinetic stretching technique

Interventional Group B

ACTIVE COMPARATOR

• Group B will be treated by conventional baseline treatment with Post-isometric Relaxation Exercises. Cervical paraspinal post isometric relaxation will be performed with the patient supine, while the therapist will slowly lift the patient's head toward the ceiling. Once a comfortable stretch will be felt, the patient is asked to push their head back (with approximately 10% of their strength), while the therapist will resist the movement; thus, creating an isometric contraction. This position is held for 8-10 seconds. The patient will be asked to inhale deeply and, upon exhalation, will be instructed to relax while the therapist will lift the patient's head a little further towards the ceiling. The protocol will be comprised of three sets of post isometric relaxation with 5 seconds rest period. Treatment will be provided twice a week for 8 weeks.

Other: Post Isometric Relaxation

Interventions

Myokinetic stretching technique (MST) is a form of myofascial release, which involves active or passive stretching and movement as well as muscle energy techniques until a desirable release from the taut band is achieved.

Interventional Group A

Post Isometric Relaxation (PIR) is the effect of the decrease in muscle tone in a single or group of muscles, after a brief period of submaximal isometric contraction of the same muscle.

Interventional Group B

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Duration of cervical pain more than 4 weeks.
  • History of positive Spurling test

You may not qualify if:

  • History of previous cervical surgery
  • Cervical spine tumor.
  • Rheumatoid arthritis, prolong steroid use and osteoporosis in cervical region.
  • Cervical spine fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allied Hospital

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Sahreen Anwar, Ph.D

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Talha Hassan Javed, Masters

CONTACT

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
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

March 10, 2023

Primary Completion

May 10, 2023

Study Completion

June 10, 2023

Last Updated

April 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations