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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05834114
Other study ID # REC/RCR & AHS/23/0108 Mustajab
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date August 1, 2023

Study information

Verified date September 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will be randomized clinical trial. Total 40 subjects will be assigned randomly by using non probability convenient into two groups. Group A will be given McKenzie protocol, with conventional physiotherapy treatment while Group B is Rhythmic stabilization group who will receive rhythmic stabilization, with conventional physiotherapy. After confirmation of diagnosis with medical history and physical examination numeric pain rating scale (NPRS) and Neck disability index (NDI) would be used as an outcome measure tools for pain and disability respectively. Measure will be taken by goniometer. After data collection from defined study setting,data will be entered and analyzed at Riphah International University, Lahore.


Description:

Neck pain is a very common ailment that results in a great deal of suffering, impairment, and financial expense. The International Association for the Study of Pain is defined as Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck. According to the study's findings, 69% of Balochistan University undergraduate students in Quetta, Pakistan, experienced neck pain. Pain in many cervical spine structures has the potential to become chronic neck pain. In epidemiologic research, pain is considered chronic if it lasts more than three months to six months, or five years. McKenzie's treatment regimens were first used in Sweden in 1985 to address mechanical spine patient issues. For these kinds of patients, protocols were often employed in the 1990s. Repeated neck retraction exercises considerably lessen the pain and restore the cervical spine's lordosis curve in individuals with spinal pain. Rhythmic Stabilization is characterized by isometric contractions against the resistance provided by the therapist, with the subject trying to maintain their position as the therapist changes the direction of resistance. Both techniques are effective in pain and range of motion in chronic neck pain. McKenzie protocol and rhythmic stabilization are both studied individually before but their effects are not compared previously.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Age 30-50 - Localized chronic neck pain for more than 3 months. Exclusion Criteria: - Participants suffering their neck pain was caused by any other complications.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mckenzie protocol
In this group 20 participants will receive McKenzie protocol with conventional physical therapy. Participants will be asked to sit to treat extension deficit. The participant will be in a comfortable sitting position with a proper back support. Head is kept in forward facing without any up and done movement (10 to 15 times). Then, he restored the neutral sitting posture, and at the end of the range of motion (ROM), he' tuck in" chin by pushing the chin with his fingers (10 to 15 times). Subsequently, the participant will be requested to return to the original position while the therapist one hand's forefinger placed alongside the participant's mandible (to stabilize the head at full retraction position), and the heel of the other hand placed on the first or second dorsal vertebra (to provide posterior-anterior force). The exercises then repeated five or six times in a Session. the session will be of 45 mins, 3 session per week.
Rhythmic Stabilization technique
In this group participants will receive Rhythmic stabilization, with Conventional physiotherapy treatment the flexion , extension exercises performed. During flexion pattern the experimenter stood at the right side of patient and used his tip of fingers at chin. The experimenter then put his left hand at anterior side of head to apply resistance. then extension pattern is resisted and asked patient to match my resistance. The experimenter provided resistance against right rotation and lateral flexion provided during the exercise in order to induce strong muscle contractions. 3 sessions of 45 minutes a week, over a period of 10 weeks.

Locations

Country Name City State
Pakistan Ghurki Trust Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale for pain NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity. On average over the past 2 day how bad has your pain been. 3 weeks
Primary Neck disability index The Neck Disability Index (NDI) (modification of the Oswestry Low Back Pain Disability Index).
(0-8%) no disability, ( 10 - 28%) mild disability, (30-48% ) moderate disability, (50- 64%) severe disability, (70-100%) complete disability
3 weeks
Secondary The Universal goniometer It is used to measure ranges of neck flexion, extension, lateral rotation(right, left), Side bending (right, left) 3 weeks
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