Neck PainNCT07084415
Effect of Laser Acupuncture on Neck and Shoulder Pain in Lactating Women
A study testing Postural correction exercise and Laser acupuncture in people with Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the effect of laser acupuncture on neck and shoulder pain in lactating women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Neck Pain
- What is being tested?
- Postural correction exercise and Laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2025to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Lactating women Suffering from cervical and shoulder pain.
- Their body mass index will be less than 30 kg/m².
- Primipara and multipara "2:3 times" women.
- six weeks to one year after childbirth.
Who cannot join
- Neurological disorders.
- Musculoskeletal disorders as cervical discopathy or shoulder impingement syndrome.
- History of cervical or shoulder surgery.
- Infection or malignancy.
- Take any medical treatment or physiotherapy interventions in the past one month.
- Fibromyalgia or myopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to investigate the effect of laser acupuncture on neck and shoulder pain in lactating women.
Read the detailed description
Breastfeeding was the most common daily living activity that caused neck and shoulder pain to become worse in lactating women, the mother's position is a head-down position to maintain eye contact with the infant, so there are possibilities of breastfeeding-related neck pain .
It was revealed that neck and shoulder pain greatly influenced the health of postpartum women; it led to a reduction in the level of quality of life of postpartum women.
Acupuncture is a choice for therapeutic intervention of patients with neck and shoulder pain and can be incorporated into rehabilitation.
laser acupuncture (LA) uses a low-intensity, non-thermal laser irradiation to stimulate the acupoints. LA may improve pain, disability, and functional levels in musculoskeletal disorders like shoulder and neck pain
- Conditions
- Neck Pain
- Being tested
- Postural correction exercise, Laser acupuncture
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural correction exerciseOther
Each participant will be given cervical thoracic spine correction exercises in the form of thoracic Roll Stretching Exercises, shoulder Bracing (Shoulder Retraction), superman Pose, chin Tuck (Cervical Retraction), five days a week for 4 weeks
Laser acupunctureDevice
A dermatograph pencil (COLOURED®) will be used to draw circles with diameters of 2 cm around the application points. Each point will be stimulated for 30 seconds.
The laser will be placed at the specific acupuncture points in shoulder and cervical regions.
Each woman in the study group will be treated by laser acupuncture for 7 minutes twice a week for 4 weeks.
Acupuncture points of the neck:
B10 (Tianzhu), GB 20 (Fengchi), GB 21 (jianjing), and EX-HN15 (jianzhongsgu). Acupuncture points of shoulder: LI 14 (Binao), LI 15 (Jianyu), TE 14 (Jianlio), LI 4 (Hegu),LI16 (Jugu), ST 38 (Tiaoko), SI 10 (Naoshu),LI 11 (Quchi),TE 15 (Tianliao),LU 1 (Zhongfu),
Parameter of laser:
wavelength: 808[nm], Operating mode: Continuous wave, Output power: 100 [mW], Power density: 333[mW/cm], area irradiated:0.3 cm2, Total time per point: 30[s], Angle of application:90 degree.
| Study group | Role | What they receive |
|---|---|---|
| Postural correction exercise group | Active comparator | The participants will receive postural correction exercises for 10 repetitions, 5 sessions per week for 4 weeks. Receives: Other: Postural correction exercise |
| Postural correction exercise and laser acupuncture group | Experimental | The participants will receive postural correction exercises (10 repetitions, 5 sessions per week for 4 weeks.), and laser acupuncture for 7 minutes twice per week for 4 weeks. Receives: Other: Postural correction exercise; Device: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The Visual analogue scale will be used to measure the pain intensity before and after the treatment program. The VAS is a 10-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain
Measured: 4 weeks
Pressure pain threshold
The pressure algometer will be used to assess pressure pain threshold before and after treatment. The examiner will determine the main 6 points of assessment on each side of cervical and shoulder girdle areas:
- 2 cm lateral to the cervical vertebrae 2 (C2) spinous processes.
- At the middle point of the upper trapezius muscle (between C7 and the acromion).
- At levator scapulae (2 cm superior to the superior angle of the scapulae).
- At mid-line of deltoid muscle. Three consecutive measurements will be made, with an interval of 30 s between them, and the average value will be recorded.
Measured: 4 weeks
cervical flexion range of motion
The patient will be in sitting position the head will be in 0-degree rotation or lateral flexion, stabilize shoulder girdle and chest by strap, The central fulcrum of goniometer will be in the external auditory meatus, the proximal arm is perpendicular, the distal arm with the base of the nares, The patient will be asked to flex her cervical until end of range. Normal cervical flexion range of motion is 80 degrees
Measured: 4 weeks
cervical extension range of motion
The patient will be in sitting position the head will be in 0-degree rotation or lateral flexion, stabilize shoulder girdle and chest by strap, The central fulcrum of goniometer will be in the external auditory meatus, the proximal arm is perpendicular, the distal arm with the base of the nares, The patient will be asked toextend her cervical until end of range. Normal cervical extension range of motion is 50-70 degrees
Measured: 4 weeks
cervical side bending
The patient will be in sitting position the head will be in 0 degree rotation or flexion or extension, stabilize shoulder girdle and chest by strap. The central fulcrum of goniometer will be over the spinous process of C7 vertebra, the proximal arm is align with spinous process of the thoracic verebrae ,the distal arm will align with dorsal of the head, the patient will be asked to side bend her cervical to end range. Normal range of motion of cervical side bending is 20-45 degrees.
Measured: 4 weeks
cervical rotation
The patient will be in sitting position the head will be in neutral position, stabilize shoulder girdle and chest by strap, Center fulcrum of the goniometer over the center of the cranial aspect of the head, Align proximal arm parallel to an imaginary line between the two acromial processes, Align distal arm with the tip of the nose. If a tongue depressor is used, align the arm of the goniometer parallel to the longitudinal axis of the tongue depressor, The patient will be asked to rotate her cervical until end of range. Normal range of motion of cervical rotation is 70-90 degrees.
Measured: 4 weeks
Shoulder flexion range of motion
The patient will be in supine lying position the knee will be 90-degree position, stabilize scapula and thorax girdle, Center fulcrum of the goniometer over the lateral aspect of the greater tubercle, Align proximal arm parallel to the midaxillary line of the thorax, Align distal arm with the lateral midline of the humerus. The patient will be asked to flex her shoulder until end of range.
Normal range of motion of shoulder flexion is 150-180 degrees.
Measured: 4 weeks
Shoulder extension range of motion
The patient will be in prone position, Center fulcrum of the goniometer over the lateral aspect of the greater tubercle, Align proximal arm parallel to the midaxillary line of the thorax, Align distal arm with the lateral midline of the humerus. The patient will be asked to extend her shoulder until end of range. Normal range of motion of shoulder flexion is 45-60 degrees.
Measured: 4 weeks
Shoulder abduction range of motion
The patient will be in supine lying position., Center fulcrum of the goniometer close to the anterior aspect of the acromial process, Align proximal arm so that it is parallel to the midline of the anterior aspect of the sternum, Align distal arm with the anterior midline of the humerus, The patient will be asked to abduct her shoulder until end of range. Normal range of motion of shoulder flexion is 150 degrees.
Measured: 4 weeks
Shoulder internal rotation range of motion
The patient will be in supine lying position, Center fulcrum of the goniometer over the olecranon process, Align proximal arm so that it is either perpendicular to or parallel with the floor, Align distal arm with the ulna, using the olecranon process and ulnar styloid for reference. The patient will be asked to internal rotate her shoulder until end of range. Normal range of motion of shoulder internal rotation is 70-90 degrees.
Measured: 4 weeks
Shoulder external rotation range of motion
The patient will be in supine lying position, Center fulcrum of the goniometer over the olecranon process, Align proximal arm so that it is either perpendicular to or parallel with the floor, Align distal arm with the ulna, using the olecranon process and ulnar styloid for reference. The patient will be asked to internal rotate her shoulder until end of range. Normal range of motion of shoulder internal rotation is 90 degrees.
Measured: 4 weeks
Secondary outcomes (3)
Functional disability
Neck disability index will be used to assess functional disability before and after treatment. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability). The maximum possible score is 50.
Measured: 4 weeks
Shoulder and pain disability index (SAPDI)
It will be used to assess the degree of shoulder pain and discomfort in performing activities of daily living. It consists of 13 items divided into two subscales: 5 items for pain and 8 items for disability. The SPADI total score is the mean of the pain and disability sub-scores. Higher score indicates more disability.
Measured: 4 weeks
Breastfeeding Self Efficacy assessment
It will be used to measure mother's confidence in her ability to breastfeed. The scale is a 14-item, self-administered instrument, where items are preceded by the phrase "I can always" and scored on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (always confident). As such, total scores can range from 14 to 70, with higher scores reflecting greater levels of breastfeeding self-efficacy.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion10 Oct 2025 (estimated)
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Mokhtar Abd El-Latif, Cairo University
- Investigators
- Hossam Hussein, Professor, Study director, Al-Azhar UniversityDoaa Osman, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084415
- Sponsor's protocol ID
- P.T.REC/012/005732
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Neck and Shoulder Pain in Lactating Women
- ClinicalTrials.gov ID
- NCT07084415
- Acronym / sponsor ID
- P.T.REC/012/005732
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of laser acupuncture on neck and shoulder pain in lactating women.
Detailed description
Breastfeeding was the most common daily living activity that caused neck and shoulder pain to become worse in lactating women, the mother's position is a head-down position to maintain eye contact with the infant, so there are possibilities of breastfeeding-related neck pain .
It was revealed that neck and shoulder pain greatly influenced the health of postpartum women; it led to a reduction in the level of quality of life of postpartum women.
Acupuncture is a choice for therapeutic intervention of patients with neck and shoulder pain and can be incorporated into rehabilitation.
laser acupuncture (LA) uses a low-intensity, non-thermal laser irradiation to stimulate the acupoints. LA may improve pain, disability, and functional levels in musculoskeletal disorders like shoulder and neck pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postural correction exercise group | Active comparator | Other: Postural correction exerciseThe participants will receive postural correction exercises for 10 repetitions, 5 sessions per week for 4 weeks. |
| Postural correction exercise and laser acupuncture group | Experimental | Other: Postural correction exercise, Device: Laser acupunctureThe participants will receive postural correction exercises (10 repetitions, 5 sessions per week for 4 weeks.), and laser acupuncture for 7 minutes twice per week for 4 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Lactating women Suffering from cervical and shoulder pain.
- Their body mass index will be less than 30 kg/m².
- Primipara and multipara "2:3 times" women.
- six weeks to one year after childbirth.
Key exclusion criteria (6 listed)
- Neurological disorders.
- Musculoskeletal disorders as cervical discopathy or shoulder impingement syndrome.
- History of cervical or shoulder surgery.
- Infection or malignancy.
- Take any medical treatment or physiotherapy interventions in the past one month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural correction exerciseEach participant will be given cervical thoracic spine correction exercises in the form of thoracic Roll Stretching Exercises, shoulder Bracing (Shoulder Retraction), superman Pose, chin Tuck (Cervical Retraction), five days a week for 4 weeks | Other | Postural correction exercise and laser acupuncture group, Postural correction exercise group |
| Laser acupunctureA dermatograph pencil (COLOURED®) will be used to draw circles with diameters of 2 cm around the application points. Each point will be stimulated for 30 seconds. The laser will be placed at the specific acupuncture points in shoulder and cervical regions. Each woman in the study group will be treated by laser acupuncture for 7 minutes twice a week for 4 weeks. Acupuncture points of the neck: B10 (Tianzhu), GB 20 (Fengchi), GB 21 (jianjing), and EX-HN15 (jianzhongsgu). Acupuncture points of shoulder: LI 14 (Binao), LI 15 (Jianyu), TE 14 (Jianlio), LI 4 (Hegu),LI16 (Jugu), ST 38 (Tiaoko), SI 10 (Naoshu),LI 11 (Quchi),TE 15 (Tianliao),LU 1 (Zhongfu), Parameter of laser: wavelength: 808[nm], Operating mode: Continuous wave, Output power: 100 [mW], Power density: 333[mW/cm], area irradiated:0.3 cm2, Total time per point: 30[s], Angle of application:90 degree. | Device | Postural correction exercise and laser acupuncture group |
Primary outcome
Pain intensity
Time frame: 4 weeks
The Visual analogue scale will be used to measure the pain intensity before and after the treatment program. The VAS is a 10-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain
Pressure pain threshold
Time frame: 4 weeks
The pressure algometer will be used to assess pressure pain threshold before and after treatment. The examiner will determine the main 6 points of assessment on each side of cervical and shoulder girdle areas: * 2 cm lateral to the cervical vertebrae 2 (C2) spinous processes. * At the middle point of the upper trapezius muscle (between C7 and the acromion). * At levator scapulae (2 cm superior to the superior angle of the scapulae). * At mid-line of deltoid muscle. Three consecutive measurements will be made, with an interval of 30 s between them, and the average value will be recorded.
cervical flexion range of motion
Time frame: 4 weeks
The patient will be in sitting position the head will be in 0-degree rotation or lateral flexion, stabilize shoulder girdle and chest by strap, The central fulcrum of goniometer will be in the external auditory meatus, the proximal arm is perpendicular, the distal arm with the base of the nares, The patient will be asked to flex her cervical until end of range. Normal cervical flexion range of motion is 80 degrees
cervical extension range of motion
Time frame: 4 weeks
The patient will be in sitting position the head will be in 0-degree rotation or lateral flexion, stabilize shoulder girdle and chest by strap, The central fulcrum of goniometer will be in the external auditory meatus, the proximal arm is perpendicular, the distal arm with the base of the nares, The patient will be asked toextend her cervical until end of range. Normal cervical extension range of motion is 50-70 degrees
cervical side bending
Time frame: 4 weeks
The patient will be in sitting position the head will be in 0 degree rotation or flexion or extension, stabilize shoulder girdle and chest by strap. The central fulcrum of goniometer will be over the spinous process of C7 vertebra, the proximal arm is align with spinous process of the thoracic verebrae ,the distal arm will align with dorsal of the head, the patient will be asked to side bend her cervical to end range. Normal range of motion of cervical side bending is 20-45 degrees.
cervical rotation
Time frame: 4 weeks
The patient will be in sitting position the head will be in neutral position, stabilize shoulder girdle and chest by strap, Center fulcrum of the goniometer over the center of the cranial aspect of the head, Align proximal arm parallel to an imaginary line between the two acromial processes, Align distal arm with the tip of the nose. If a tongue depressor is used, align the arm of the goniometer parallel to the longitudinal axis of the tongue depressor, The patient will be asked to rotate her cervical until end of range. Normal range of motion of cervical rotation is 70-90 degrees.
Shoulder flexion range of motion
Time frame: 4 weeks
The patient will be in supine lying position the knee will be 90-degree position, stabilize scapula and thorax girdle, Center fulcrum of the goniometer over the lateral aspect of the greater tubercle, Align proximal arm parallel to the midaxillary line of the thorax, Align distal arm with the lateral midline of the humerus. The patient will be asked to flex her shoulder until end of range. Normal range of motion of shoulder flexion is 150-180 degrees.
Shoulder extension range of motion
Time frame: 4 weeks
The patient will be in prone position, Center fulcrum of the goniometer over the lateral aspect of the greater tubercle, Align proximal arm parallel to the midaxillary line of the thorax, Align distal arm with the lateral midline of the humerus. The patient will be asked to extend her shoulder until end of range. Normal range of motion of shoulder flexion is 45-60 degrees.
Shoulder abduction range of motion
Time frame: 4 weeks
The patient will be in supine lying position., Center fulcrum of the goniometer close to the anterior aspect of the acromial process, Align proximal arm so that it is parallel to the midline of the anterior aspect of the sternum, Align distal arm with the anterior midline of the humerus, The patient will be asked to abduct her shoulder until end of range. Normal range of motion of shoulder flexion is 150 degrees.
Shoulder internal rotation range of motion
Time frame: 4 weeks
The patient will be in supine lying position, Center fulcrum of the goniometer over the olecranon process, Align proximal arm so that it is either perpendicular to or parallel with the floor, Align distal arm with the ulna, using the olecranon process and ulnar styloid for reference. The patient will be asked to internal rotate her shoulder until end of range. Normal range of motion of shoulder internal rotation is 70-90 degrees.
Shoulder external rotation range of motion
Time frame: 4 weeks
The patient will be in supine lying position, Center fulcrum of the goniometer over the olecranon process, Align proximal arm so that it is either perpendicular to or parallel with the floor, Align distal arm with the ulna, using the olecranon process and ulnar styloid for reference. The patient will be asked to internal rotate her shoulder until end of range. Normal range of motion of shoulder internal rotation is 90 degrees.
3 secondary outcomes
Functional disability
Time frame: 4 weeks
Shoulder and pain disability index (SAPDI)
Time frame: 4 weeks
Breastfeeding Self Efficacy assessment
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hossam Hussein, Professor study director
Al-Azhar University
Doaa Osman, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural correction exercise and Laser acupuncture in people with Neck Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara Abdellatif, Master (01020098852, yara.mokhtaar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.