NCT05732246

Brief Summary

As Non specific chronic neck pain is effecting quality of life in many ways, there are many studies evaluating the methods to treat that problem. This study aims to determine Effect of first rib mobilization with balloon breathing exercises in non specific chronic neck pain. Patients would be divided into two groups and both received conventional treatment. Group A got conventional treatment only but Group B got 1st rib mobilization with balloon breathing exercises in addition.

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 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

February 7, 2023

Last Update Submit

August 26, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Neck Disability Index (change is being assessed)

    Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. 0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability

    Change from Baseline measures at 8 weeks

  • Numeric Pain Rating Scale (change is being assessed)

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"

    Change from Baseline measures at 8 weeks

  • Single Breath Count (change is being assessed)

    Participants will be requested to count out loud after maximal inspiration. The ability to reach a count of 50 is considered as normal respiratory function

    Change from Baseline measures at 8 weeks

  • Chest Wall Expansion (change is being assessed)

    Take an inches tape and encircle chest around the level of nipple. Take measurements at the end of deep inspiration and expiration. Normally, a 2-5" of chest expansion can be observed

    Change from Baseline measures at 8 weeks

Study Arms (2)

Conventional treatment group

NO INTERVENTION

Hot pack and TENS at neck for 10minutes. Therapeutic ultrasound for 5 minutes Soft tissue techniques (gliding and kneading) was applied at a slow speed for 5 minutes over the neck muscles. Gentle stretching and strengthening exercises

First rib mobilization with balloon breathing exercises group

EXPERIMENTAL

Patient was in supine position, placing the soles of his feet against the wall so that the ankle, knee, and thigh joints are at a 90-degree angle. The subject placed a 3-4-inch ball between his/her knees, which he/she has to maintain through the pressure of the internal thigh muscles during the whole training period and puts his/her back on the bed. Holds the right hand above the head and the left hand with the balloon. Meanwhile examiner palpated 1st rib with head in left side flexion. Patient was then asked to inhale through the nose in three-four seconds and then exhales slowly into the balloon. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depress the first rib as able during exhalation.

Other: First rib mobilization with balloon breathing exercises

Interventions

Patient was in the supine position, placing the soles of his feet against the wall so that the ankle, knee, and thigh joints are at a 90-degree angle. The subject placed a 3-4-inch ball between his/her knees, which he/she has to maintain through the pressure of the internal thigh muscles during the whole training period and puts his/her back on the bed. Holds the right hand above the head and the left hand with the balloon. Meanwhile examiner would palpate 1st rib with head in left side flexion. Patient was then asked to inhale through the nose in three-four seconds and then exhales slowly into the balloon. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depressed the first rib as able during exhalation.

First rib mobilization with balloon breathing exercises group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group 18-45 years
  • Gender: Male, Female
  • Patients with non-specific chronic neck pain referred by physician or orthopedic surgeon
  • Computer users, mobile users and those with routine of prolonged sitting

You may not qualify if:

  • Any H/o neurological or vestibular disorders.
  • Any H/o Cervical Trauma or surgery
  • Any history of Physiotherapy treatment for the cervical region within the previous three months
  • cardiac or respiratory insufficiency
  • Pregnancy
  • Neoplasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Feroza Nawaz, MSOMPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 16, 2023

Study Start

February 6, 2023

Primary Completion

June 30, 2023

Study Completion

August 24, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations