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Investigating the added effects of subscapularis muscle dry needling to exercise therapy on pain, kinematics, and cervical position sense in individuals with forward head posture

Protocol summary

Study aim
Investigating the added effects of subscapularis muscle dry needling to exercise therapy on pain, kinematics, and cervical position sense in individuals with forward head posture
Design
Clinical trial, with a control group, double-blind, randomized, on 32 patients. A random number table is used for randomization, with 8 blocks and a block size of 4.
Settings and conduct
Two groups of subjects are selected from among those with head pronation. Subjects in one group receive exercise therapy and subjects in the other group receive dry needling of the subscapularis muscle in addition to exercise therapy. The examiner and the therapist are not the same, and thus blinding of the evaluator will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women between the ages of 18 and 50, craniovertebral angle less than 50 degrees, shoulder angle less than 52. Exclusion criteria: Having central nervous system problems, musculoskeletal problems, congenital neck problems, spondylolisthesis, taking any pharmacological or non-pharmacological treatment for neck pain and postural disorders, any mental disorder such as anxiety and depression, cancer and pregnancy, conditions that dry needling cannot be used
Intervention groups
In the intervention group, participants will receive dry needling of the subscapularis muscle along with exercise therapy, and in the control group, participants will receive exercise therapy alone. Both groups will undergo 10 treatment sessions, 3 sessions per week. The exercises for both treatment groups are the same and include stretching exercises and strengthening exercises. At the end of sessions one, three, five, seven, and nine, individuals will undergo dry needling of the subscapularis muscle. To perform dry needling (5 sessions), a Huan Qiu needle, 30 mm in diameter and 50 mm high, made in China, is used.
Main outcome variables
Craniovertebral angle, shoulder angle, pain, neck range of motion, neck position sense

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241004063260N2
Registration date: 2025-04-02, 1404/01/13
Registration timing: prospective

Last update: 2025-04-02, 1404/01/13
Update count: 0
Registration date
2025-04-02, 1404/01/13
Registrant information
Name
Farzaneh Yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 2600
Email address
yazdani_far@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2025-10-12, 1404/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the added effects of subscapularis muscle dry needling to exercise therapy on pain, kinematics, and cervical position sense in individuals with forward head posture
Public title
The effects of adding subscapularis muscle dry needling to exercise therapy on symptoms of individuals with forward head posture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women and men between the ages of 18 and 50 Craniovertebral angle less than 50 degrees Shoulder angle less than 52 degrees
Exclusion criteria:
Having central nervous system problems Having musculoskeletal problems Having congenital neck problems Having spondylolisthesis Taking any pharmacological or non-pharmacological treatment for neck pain and postural disorders Having any mental disorder such as anxiety and depression Cancer Pregnancy The patient's fear of needles The patient's reluctance and negative beliefs about this method The patient's inability to obtain consent (cognitive problems and advanced age) The patient has a medical emergency or acute medical condition The patient has lymphedema in a region or an organ The patient has severe neutropenia or thrombocytopenia
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study is permutation (block) randomization. Considering 8 blocks of 4 in two groups and adding individuals with an allocation ratio of 1:1 in each group, 32 patients are studied in two groups of 16. Randomization is performed using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, assessment and treatment are performed separately by two physiotherapists, with the assessing physiotherapist blinded to the participants' treatment. Also statistical analysis is performed by a statistician who is blinded to the participants' allocation to groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Shiraz School of Rehabilitation Sciences
Street address
Ethics Committee, Vice President for Research, School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Hospital, Sadra Town Road
City
Shiraz
Province
Fars
Postal code
7198754361
Approval date
2025-02-05, 1403/11/17
Ethics committee reference number
IR.SUMS.REHAB.REC.1403.011

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
Craniovertebral angle
Timepoint
Before the start of the intervention, after the intervention and two weeks after the intervention
Method of measurement
The craniovertebral angle is the angle between two anatomical landmarks (the spinous process of the seventh cervical vertebra and the outer part of the tragus of the ear) that is examined with the Kinovea software.

Secondary outcomes

1

Description
Shoulder angle
Timepoint
Before the intervention, after the intervention, and two weeks after the intervention
Method of measurement
The shoulder angle is the angle formed by the intersection between the horizontal line passing through the acromion and the line connecting the spinous process of the seventh cervical vertebra to the acromion, and is measured with the Kinovea software.

2

Description
Pain
Timepoint
Before the intervention, after the intervention, and two weeks after the intervention
Method of measurement
Visual Analogue Scale

3

Description
Cervical positioning sense
Timepoint
Before the intervention, after the intervention, and two weeks after the intervention
Method of measurement
Joint position error test

4

Description
Cervical range of motion
Timepoint
Before the intervention, after the intervention, and two weeks after the intervention
Method of measurement
Goniometry

Intervention groups

1

Description
Intervention group: Dry needling of the subscapularis muscle combined with exercise therapy. Individuals in this group will undergo 10 sessions of treatment, 3 sessions per week. The exercises will include stretching and strengthening exercises, and at the end of sessions one, three, five, seven, and nine, individuals will undergo dry needling of the subscapularis muscle. To perform dry needling, the participant is asked to lie supine, with the shoulder in 90 degrees of abduction and 90 degrees of external rotation. The therapist uses one hand to pull the participant's shoulder further outward, palpating the outer edge of the scapula. The latissimus dorsi tendon is identified and lifted using a pincer grip to provide better access to the muscle. The needle is then inserted parallel to the chest and perpendicular to the anterior surface of the scapula. The needle entry site is cleaned with alcohol and cotton. Dry needling is performed on the muscle at three points, each point for 1 minute using a fast in-fast out method. A Chinese-made Huan Qiu needle, 30 mm in diameter and 50 mm in height, is used. Assessments will be conducted before treatment, immediately after treatment, and two weeks later.
Category
Treatment - Other

2

Description
Control group: Exercise therapy. Individuals in this group will undergo 10 sessions of therapy, 3 sessions per week. The exercises in this group are exactly the same as those in the intervention group and include stretching and strengthening exercises. Assessments will be conducted before treatment, immediately after treatment, and two weeks later.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of the Faculty of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Yazdani
Street address
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3212 2600
Email
rehabdep@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Research and Technology Vice Chancellor, 7th floor, Shiraz University of Medical Sciences Central Building, Zand Street
City
Shiraz
Province
Fars
Postal code
7198754361
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?
No
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 Yazdani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Hospital, Sadra Town Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
yazdani_far@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Yazdani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Hospital, Sadra Town Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
yazdani_far@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Yazdani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Hospital, Sadra Town Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
yazdani_far@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Data collection form including primary and secondary outcomes, informed consent form, and SPSS file
When the data will become available and for how long
After the publication of the study results
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 via email yazdani_far@sums.ac.ir
What processes are involved for a request to access data/document
Maximum one month after sending the request via email
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