Effects of Diaphragm Manual Therapy Verses Sustained Natural Apophyseal Glide in Mechanical Neck Pain

October 10, 2024 updated by: Riphah International University

Effects of Diaphragm Manual Therapy Versus Sustained Natural Apophyseal Glide on Pain, Range of Motion and Functional Disability in Patients With Mechanical Neck Pain

Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Study aimed to compare diaphragm manual therapy and Sustained Natural Apophyseal Glide on pain, range of motion and functional disability in patients with mechanical neck pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project will be a Randomized Clinical Trial conducted to check the effects of Diaphragm manual therapy versus sustained natural apophyseal glide on pain, range of motion and functional disability in patients with mechanical neck pain at Sehat Medical Complex Lahore through non-probability convenient sampling technique on 34 patients will be allocated using simple random sampling through Computer generated Randomization into Group A and Group B. Group A will be treated with Diaphragm Manual Therapy and baseline treatment was given and Group B with Sustained Natural Apophyseal Glide and baseline treatment was given. All Exercise were performed 3 times a week for total 4 weeks. Outcome measures will be conducted through NPRS for pain, ROM measured by Goniometer, and Neck Disability Index (NDI) for Disability after 4 weeks. Data was analyzed during SPSS software version 25. After assessing the normality of data by the Shapiro-Wilk test, it decided whether either parametric or non-parametric tests were used within a group or between two groups.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Sehat Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age group between 18 and 40 years
  • Both gender male and female
  • Individuals having localized pain or stiffness in the cervical spine or both combined between C3 and C7 without upper-limb radiculopathy
  • Pain reported on NPRS score ˃3 to <7/10 in neck region for more than 3 months.
  • Limited Neck ROM
  • Negative Spurling's test, traction test, upper limb tension test, and shoulder abduction test

Exclusion Criteria:

Patients were excluded if they were diagnosed with the following conditions for ˃6 months

  • Tuberculosis, carcinoma, heart disease, and osteoporosis
  • Neural disorders due to prolapsed intervertebral disc
  • Any trauma or localized infection in neck region
  • Upper motor neuron disease, cervical stenosis, and metabolic diseases in bone and joint
  • Hyper flexibility
  • Open sores
  • Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants
  • Psychiatric diseases such as phobia/obsession and depression
  • Allergy to hot pack
  • Patients with history of surgery in cervical spine region with in a year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Diaphragm Manual Therapy
Group A were receiving diaphragm Manual therapy by Leon Chaitow. Subsequently, in order to indirectly stretch and mobilize the fibres of the diaphragm, diaphragmatic manual therapy was used, which should result in improved muscle contraction and reduced tension. The doming diaphragmatic technique and the manual diaphragmatic release technique, both as described by Leon Chaitow, will be among the experimental methods employed. For 10 min, both manoeuvres were performed in 2 sets of 10 repetitions each, separated by 1 min.
Other: Baseline treatment
Transcutaneous Electric Nerve Stimulation (TENS) of Care Vision company will be applied, with a pulse duration of 250 microseconds at a frequency of 80 Hz for 15 min in the suboccipital region and the trapezius bilaterally.
Active Comparator: Group B: Sustained Natural Apophyseal Glide (SNAGs)
Group B has received the Sustained natural apophyseal glide (SNAGS). Treatment procedure for SNAGs was sustained natural apophyseal glides whereby the patient attempts to actively move a painful or stiff joint through its ROM while the therapist overlays an accessory glide parallel with the treatment plane. SNAG mobilization was given to a patient (as defined by Mulligan) sitting on a chair. At the same time, the treating physiotherapist stood behind by placing the medial border of the distal phalanx of the thumb on the spine of one vertebra above the affected region. The glides were given with the tip of the thumb placed at an angle of 45° along the eyeball direction reinforced by another thumb. In the session, glides were repeated six times, and three sets were given at C3-C7 cervical levels.
Other: Baseline treatment
Transcutaneous Electric Nerve Stimulation (TENS) of Care Vision company will be applied, with a pulse duration of 250 microseconds at a frequency of 80 Hz for 15 min in the suboccipital region and the trapezius bilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: upto 4 weeks
The primary outcome was pain assessment by the Numeric Pain Rating Scale (NPRS). This is a reliable self-reported 11-point numeric scale, where each number reflects the intensity of the pain referred by the patient: "0" stands for "no pain" and "10" for "the worst possible pain". Patients verbally selected 3 values that were most in line with the intensity of pain that they had experienced in the previous 24 h, corresponding to current pain and to his/her best and worst pain. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 h. NPRS was assessed before and after each treatment session. The reliability is (r = 0.96 and 0.95, respectively) and validity correlations range from 0.86 to 0.95
upto 4 weeks
Neck disability Index (NDI)
Time Frame: upto 4 weeks
Disability was assessed using the Urdu version of the Neck Disability Index (NDI). This is a reliable scale and was self-assessed by the patients and filled in at the beginning and at the end of the whole treatment. The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage. The reliability is between 0.50 and 0.98.
upto 4 weeks
Universal Goniometer
Time Frame: upto 4 weeks
An instrument called a goniometer was used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer. The reliability is (r = .58). Neck ROM will be measured in this study using a Universal Goniometer.
upto 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Anam Akram, MSPT*, Riphah International University,Lahore
  • Study Director: samrood Akram, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0196 Anam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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