Comparison Of Direct Myofascial Release And Bowen's Technique For Non-Specific Neck Pain

February 1, 2022 updated by: Riphah International University
Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day. Non-specific neck pain is the common cause of neck symptoms that is mainly due to mechanical causes, postural problem, depression, anxiety or occupational activities. Poor posture causes abnormal muscle loading and muscle injury

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neck pain is described as pain in the neck region that may or may not radiate to both the upper limbs and that will last for at least one day.Poor posture causes abnormal muscle loading and muscle injury.It becomes a constant source of neck pain and instability. It reduces range of motion and weakens the shoulder and neck muscles. According to a population based survey the prevalence of lifetime neck pain ranges from 67% to 87%.

Trigger points cause myofascial pain syndrome which is among the leading cause of non-specific neck pain. Myofascial release technique (MRT) is often used to treat non-specific neck pain.Another therapy that focuses on myofascial work is Bowen therapy that follows a dynamic approach to release fascia and muscles. The technique involves very gentle cross fiber movements that are applied on fascia, muscles, tendons and viscera to induce the effect. The technique is applied at specific body regions following specific sequences with regular rest intervals that cause fascial stretching. The technique consists of slightly picking up muscles and then rolling the muscles to direct them toward a specific region of body. The rest periods help the body to integrate and absorb the effects of therapy. The sensory impulses caused by the Bowen therapy interact with nervous system and realign and correct the disturbed mechanisms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Rawalpindi, Punjab, Pakistan, 46000
        • Pakistan Railway General Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic non-specific neck pain ≥ 3 months without symptoms radiating to the upper limbs
  • Presence of a maximum of 1-2 active Myofascial Trigger Points
  • Pain of more than 3 on a NPRS

  • For the diagnosis of a Trigger Point, compliance with the following criteria:

    • (1) A hypersensitive spot in a palpable taut band,
    • (2) Palpable or visible local twitch on pincer palpation
    • (3) Reproduction of referred pain elicited by palpation of the sensitive spot.

Exclusion Criteria:

  • Diagnosed with cervical radiculopathy or myelopathy
  • Neck Pain due to trauma, fractures, or whiplash; neoplasia, severe osteoporosis, infectious, or inflammatory processes;
  • Patients with pacemakers, congenital anomalies, previous neck surgery
  • Patients diagnosed with fibromyalgia syndrome according to the American College of Rheumatology criteria

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Direct myofascial release treatment
Myofascial Release will be applied with Forearm and/or ulnar border of the palm. Deep Pressure will be applied and glided medially towards the base of the neck and/ or towards the upper scapular region
Other: Direct myofascial release treatment
Myofascial Release will be applied with Forearm and/or ulnar border of the palm. Deep Pressure will be applied and glided medially towards the base of the neck and/ or towards the upper scapular region
Active Comparator: Bowen therapy
Thumb of the therapist will be placed on the top of the targeted muscle. The skin will be carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb will be flattened in the medial direction, when this happened the muscle would plop or respond in some way.
Other: Bowen therapy
Thumb of the therapist will be placed on the top of the targeted muscle. The skin will be carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb will be flattened in the medial direction, when this happened the muscle would plop or respond in some way.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale
Time Frame: for two weeks
The Numeric pain rating scale is an 11-point numeric scale, it is the segmented numeric version of the visual analog scale. Subjects will be asked to mark/select a whole number for 0-10 that best describes their perceived pain intensity of the last 24 hours. zero indicates no pain and 10 is worst possible pain. assessment to be done at base line and after 2 weeks
for two weeks
Goniometer for Cervical Range of Motion
Time Frame: for two weeks
The active cervical range of motion (CROM) will be measured in sitting posture by using a universal goniometer, which consists of two arms; one that is stationary and one that is moveable. assessment to be done at base line and after 2 weeks
for two weeks
Neck Disability Index
Time Frame: for two weeks
it is a 10-item self-report questionnaire that measures the patient's disability related to his/her neck pain. It is the most commonly used questionnaire for neck disability; its reliability and validity has been demonstrated in many literatures and languages.its minimum score is zero no disability and 50 is maximum disability. Assessment to be done at base line and after 2 weeks
for two weeks
Depression Anxiety Stress Scale (DASS)
Time Frame: for two weeks
DASS is a reliable and validated tool commonly administered to measure the level of stress, depression and anxiety of the respondent. It is 42-item questionnaire that focuses on low mood, motivation, self-esteem, physiological arousal, perceived panic, fear, tension and irritability. Respondent answer each question by indicating the extent on a 4-point scale. In this study Urdu version of DASS is used which has concurrent validity of .87 for normal subjects and .84 for clinical population and .89 reliability. its minimum value is zero which is normal and maximum is 34 plus which is stress. Assessment to be done at base line and after 2 weeks
for two weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC-00942 Shahzana khalid

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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