Comparison of suboccipital myofascial release and diaphragm myofascial release on posture, pain and functional ability in patients with symptomatic forward head posture: A randomized clinical trial study
Comparison of the effects of suboccipital myofascial release and diaphragm myofascial release on posture, pain, and functional ability in patients with symptomatic forward head posture aged 18 to 40 years
Design
A controlled, double group, single blinded (assessor), randomized (Randomizer site), phase 3 clinical trial on 48 patients.
Settings and conduct
The study at Shiraz's School of Rehabilitation Sciences will compare diaphragm release, suboccipital release, and a control groups. Manual techniques are applied thrice weekly for four weeks, alongside therapeutic exercises for all groups. Blinding of evaluator is maintained by separating treatment and assessment roles.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 18 to 40 years; Neck pain for at least the past 6 weeks; CVA less than 49.9 degrees; Diaphragm tenderness; Average daily use of mobile phones and computers equal to 4 hours or more, or 4 continuous hours of computer use in a seated position.
Exclusion criteria:
Visual and auditory impairments;
Neurological disorders;
Balance disorders;
History of surgery in the neck and spine area;
History of any trauma to the cervical spine, such as whiplash injury
Intervention groups
Intervention groups: One of the intervention groups will receive suboccipital muscle release, and the other group will receive diaphragm muscle release. Both groups will also be provided with a common therapeutic exercise program.
Control group: This group will receive only the same therapeutic exercise program.
Comparison of suboccipital myofascial release and diaphragm myofascial release on posture, pain and functional ability in patients with symptomatic forward head posture: A randomized clinical trial study
Public title
Comparison of suboccipital and diaphragm muscle release on posture, pain, and functional ability in patients with symptomatic forward head posture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 18 to 40 years
Having reported neck pain for at least the past 6 weeks
CVA angle must be less than 49.9 degrees
Individuals must present tenderness in the diaphragm
Average daily use of mobile phones and computers should be 4 hours or more, or 4 continuous hours of computer use in a seated position
Exclusion criteria:
Visual and auditory impairments
Neurological disorders
Balance disorders
History of surgery in the neck and spine area
History of any trauma to the cervical spine, such as whiplash injury
Cognitive impairments
Inflammatory diseases such as rheumatoid arthritis
History of any fracture in the neck area
Congenital defects in the neck area (e.g., torticollis)
Respiratory diseases and shingles
Professional athletes
Cervical spinal canal stenosis
Radicular pain related to the neck area
Malignancy
Fibromyalgia
Undergoing physiotherapy treatment in the past six months
Use of painkillers, anti-inflammatory drugs, or muscle relaxants in the past 72 hours
History of clavicle and rib fractures
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment method in this study will be the blocked permutation method (number of blocks 8 and block size 4) which will be generated using randomizer site. The samples will be assigned in a 1:1 ratio. Opaque, sealed envelopes will be used to conceal the assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The individual who performs the assessments is separate from the one who administers the treatments, and neither is aware of the other's work. The person responsible for randomization is also independent from both of the aforementioned individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ethics committee, Research and Technology Vice-Chancellor, 7th floor, Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7198754361
Approval date
2025-05-07, 1404/02/17
Ethics committee reference number
IR.SUMS.REHAB.REC.1404.006
Health conditions studied
1
Description of health condition studied
Forward head posture
ICD-10 code
R29.3
ICD-10 code description
Abnormal posture
Primary outcomes
1
Description
Head postural status
Timepoint
Before intervention; One day after intervention period
Method of measurement
Craniovertebral angle
2
Description
Pain intensity
Timepoint
Before intervention; One day after intervention period
Method of measurement
Numerical pain rating scale
3
Description
Functional ability
Timepoint
Before intervention; One day after intervention period
Method of measurement
Neck disability index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Diaphragm release and therapeutic exercise. To perform diaphragm release, the patient sits upright, and the therapist, positioned behind them, wraps his/her hands around the patient's rib cage in such a way that their fingers are placed beneath the costal margin. To relax the rectus abdominis muscle, the patient bends their torso forward. During the patient's exhalation, the therapist grasps the lower ribs from the costal margin area and maintains this position for 5 to 7 minutes.
Category
Treatment - Other
2
Description
Intervention group2: Suboccipital release and therapeutic exercise. To perform suboccipital release, the patient is asked to lie on his/her back while the therapist sits on a chair at the level of the patient’s head. The therapist’s elbows are supported by the treatment table, and the forearms are positioned in supination. The patient is instructed to rest their head on the therapist’s palms. Then, the therapist places the pads of four fingers from both hands on either side of the second cervical vertebra, just below the occipital area, and maintains pressure until a sensation of melting is felt. The duration of the intervention is 4 minutes.
Category
Treatment - Other
3
Description
Control group: Therapeutic exercise
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Rehabilitaion School, Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Haghighat
Street address
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Email
rehabdep@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Research and Technology Vice-Chancellor, 7th floor, Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Haghighat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Email
haghighat_fa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Haghighat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Fax
Email
haghighat_fa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Haghighat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Fax
Email
haghighat_fa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information collection form including primary and secondary outcomes, informed consent form and SPSS file
When the data will become available and for how long
After publication the results of the study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only for recording information in scientific databases
From where data/document is obtainable
Correspondence with the project manager by email. Haghighat_fa@yahoo.com
What processes are involved for a request to access data/document
Maximum one month after sending the request by email