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Completed

NCT Number: NCT05347251

Effects of Cervicothoracic Mobility Program on Low Back Pain

The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like hot packs and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like the hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles.

The session will be around 40 to 45 min for each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion, and function with NPRS (numeric pain rating scale), goniometer, and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy department of Syed medical complex Sialkot

Sialkot, Pakistan

About this study

Chronic back pain is usually age-related, but can also result from a prior injury. The most common causes include arthritis of the spine, a sedentary lifestyle, and any injury or disc-related problems. Joint mobilization is a physical therapy technique designed to relieve pain and muscle spasms, release tension and improve flexibility in a joint. The aim of this study is to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like a hot pack and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles. The session will be around of 40 to 45 min on each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometer and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Both genders.
  • Age 18-50 years. NPRS between 3 and 6
  • Subjects diagnosed with chronic back pain with minimum 6 months of chronicity
  • ODI score 21 to 40
  • There should be no radiating pain to legs of participants.

Exclusion criteria

  • Patients with Systemic soft tissue disease and bony disease will be excluded from the study.
  • Pregnant women will be excluded from the study.
  • Patients with previous orthopedic and neurosurgical surgery will be excluded from the study.
  • Patients with any Red flags (Ankylosing spondylitis, spondylolisthesis, Slipped discs, spinal tumor, spinal stenosis, cauda equine syndrome, and spine infection) will be excluded.
  • Patients with a positive Faber test for SIJ dysfunction will be excluded

Treatment and study plan

Cervicothoracic mobility program

Other

Participants in this group will receive mobilization at a cervical and thoracic level along with conventional physical therapy protocol like Hot packs and exercise therapy.

At the cervical, PA glides (central) and transverse glides will be given for mobilization.

At thoracic, PA glides (central) and transverse glides will be given for mobilization.

Exercise therapy includes stretching and strengthening both cervical and thoracic muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck

stretching exercises (flexors, extensors, side benders

and rotators) will perform as well. Similarly, at the thoracic

level, strengthening and stretching of thoracic muscle will be performed

conventional treatment

Other

It will be the control group. The participants who will be allocated in this group receive the only conventional physical therapy protocol (Hot pack and exercise therapy). Exercise therapy includes stretching and strengthening of neck and upper back muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck stretching exercises (flexors,

extensors, side benders, and rotators) will perform

as well. Similarly at the thoracic level, strengthening and stretching of thoracic muscle will be performed.

Primary outcomes

  1. NPRS

    Time frame: 3rd Week

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain

  2. ODI

    Time frame: 3rd Week

    The Oswestry Disability Index is an extremely important tool that researchers and disability evaluators use tomeasure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools

  3. Goniometer

    Time frame: 3rd Week

    A goniometer is an instrument which measures the available range of motion at a joint.

    (Also mention all information which ROM u want to check)

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Cervicothoracic Mobility Program on Pain, Range of Motion and Function in Patients With Chronic Back Pain

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 26, 2022
Registry last updated
Apr 3, 2023

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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