NCT06656143

Brief Summary

The air of this RCT is to evaluate the effects Diaphragmatic Myofascial Release technique on chest expansion and heart rate in patients with thoracic kyphosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

October 16, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

October 23, 2024

Last Update Submit

September 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Chest Expansion

    Diaphragm is facially and mechanically attached to thoracic spine, so releasing tension in diaphragmatic muscles will improve biomechanics, resulting in greater chest expansion and improving heart rate.

    3rd week

  • Heart Rate

    Diaphragm a thin, flat muscle that separates the thoracic and abdominal cavity, is the primary muscle of respiration, which plays significant role in breathing and physiological regulation. Hyper kyphosis negatively affects chest expansion and heartrate by causing limited mobility in thoracic cage. Diaphragm is facially and mechanically attached to thoracic spine, so releasing tension in diaphragmatic muscles will improve biomechanics, resulting in greater chest expansion and improving heart rate

    3rd week

Secondary Outcomes (1)

  • Thoracic Kyphosis

    3rd week

Study Arms (2)

Diaphragmatic Myofascial release

EXPERIMENTAL

Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction.

Other: Diaphragmatic Myofascial Release

Traditional Physical therapy

ACTIVE COMPARATOR

Strengthening Deep Cervical Flexors Strengthening Shoulder Retractors Stretch Cervical Extensors Stretch Pectoralis Muscle

Other: Traditional Physical therapy

Interventions

The exercise program included the strengthening of the deep cervical flexor and shoulder retractor muscles and also stretching of the pectoralis and cervical extensor muscles. (3 sets of 12 repetitions) Strengthening Deep Cervical Flexors Lying chin tuck Lying chin tuck with head lift. Strengthening Shoulder Retractors Standing shoulder pull back with elastic Shoulder pull back with weight Stretch Cervical Extensors Chin drop Stretch Pectoralis Muscle Bilateral Pectoral stretch

Traditional Physical therapy

To release the diaphragm, the patient was positioned in the supine position. The therapist stood at the head of the patient. The therapist made manual contact bilaterally under the costal cartilages of the lower ribs (7th to 10th) with hypothenar regions of the hands and last three fingers. During the patient's inspiration, the therapist was gently pulling the points of hands contacts toward the head and slightly laterally, while elevating the ribs simultaneously. During exhalation, the therapist deepened hand contacts towards the inner costal margins Exercise Program (3 sets of 12 reps) Strengthening deep cervical flexors Strengthening shoulder retractors Stretching Cervical Extensors Stretching Pectoralis Muscle

Diaphragmatic Myofascial release

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and females
  • age 18-40 years
  • patients who consented to the purposes of this study and participated voluntarily.
  • patients with thoracic kyphosis ≥40

You may not qualify if:

  • Participant failing to fall in this category would be excluded of the study.
  • Vertebrobasilar insufficiency, rib fracture, rib dislocation and/or signs of serious pathology (e.g., malignancy, inflammatory disorder, infection);
  • History of cervical spine surgery in previous 12 months
  • Signs of cervical radiculopathy or myelopathy; and vascular syndromes such as basilar insufficiency.
  • Patients with diagnosed any respiratory condition.
  • Patient diagnosed with hypertension or taking any medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal Capital, 45750, Pakistan

Location

Related Publications (3)

  • Singla D, Veqar Z. Association Between Forward Head, Rounded Shoulders, and Increased Thoracic Kyphosis: A Review of the Literature. J Chiropr Med. 2017 Sep;16(3):220-229. doi: 10.1016/j.jcm.2017.03.004. Epub 2017 Sep 28.

    PMID: 29097952BACKGROUND
  • Park SJ, Kim SH, Kim SH. Effects of Thoracic Mobilization and Extension Exercise on Thoracic Alignment and Shoulder Function in Patients with Subacromial Impingement Syndrome: A Randomized Controlled Pilot Study. Healthcare (Basel). 2020 Sep 2;8(3):316. doi: 10.3390/healthcare8030316.

    PMID: 32887287BACKGROUND
  • Lewis JS, Valentine RE. Clinical measurement of the thoracic kyphosis. A study of the intra-rater reliability in subjects with and without shoulder pain. BMC Musculoskelet Disord. 2010 Mar 1;11:39. doi: 10.1186/1471-2474-11-39.

    PMID: 20193055BACKGROUND

Study Officials

  • Shamaila Yaqub, MS OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

October 16, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

September 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations