Effect of Laser Acupuncture on Neck and Shoulder Pain in Lactating Women

NCT07084415 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005732
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of laser acupuncture on neck and shoulder pain in lactating women.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (11)

• 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

  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.

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  4 weeks

Secondary Outcomes (3)

• Functional disability

  4 weeks

• Shoulder and pain disability index (SAPDI)

  4 weeks

• Breastfeeding Self Efficacy assessment

  4 weeks

Study Arms (2)

Postural correction exercise group

ACTIVE COMPARATOR

The participants will receive postural correction exercises for 10 repetitions, 5 sessions per week for 4 weeks.

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.

Other: Postural correction exercise; Device: Laser acupuncture

Interventions

Postural correction exercise OTHER

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

Postural correction exercise and laser acupuncture group; Postural correction exercise group

Laser acupuncture DEVICE

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.

Postural correction exercise and laser acupuncture group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Yara Mokhtar Abd El-Latif

Cairo, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hossam Hussein, Professor

  Al-Azhar University

  STUDY DIRECTOR

• Doaa Osman, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Yara Abdellatif, Master

CONTACT

01020098852; yara.mokhtaar@gmail.com

Elham Hassan, PHD

CONTACT

01206146539; elhamramadan70@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start: July 25, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 25, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

EG (1)