NCT05074641

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

September 29, 2021

Last Update Submit

February 1, 2022

Conditions

Keywords

PainRange of motionMyofascial releaseBowen therapyAnxiety

Outcome Measures

Primary Outcomes (4)

  • Numeric pain rating scale

    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

    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

    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)

    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

Study Arms (2)

Direct myofascial release treatment

EXPERIMENTAL

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

Bowen therapy

ACTIVE COMPARATOR

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

Interventions

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

Direct myofascial release treatment

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.

Bowen therapy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Neck PainPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

February 15, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

February 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations