NCT07869667

Brief Summary

Improvement in pain and range of motion (ROM) outcomes for stroke cases suffering from complex regional pain syndrome (CRPS) can be attained through Electro-acupuncture therapy, which in turn improve functional independence and reduces financial strain on both patients and their families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable stroke

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

January 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

October 6, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

StrokeComplex Regional Pain SyndromeElectro-acupuncture

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale

    Subjective pain assessment

    4 weeks

  • Kinovea-based measurement for shoulder flexion

    Shoulder flexion range of motion (ROM) assessment was conducted using Kinovea-2020 software following a standardized protocol

    4 weeks

  • Arabic version of DASH questionnaire

    Designed to quantify functional limitations and symptoms affecting the arm, shoulder, and hand region

    4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Consisted of 20 patients who received a selected physical therapy program and electroacupuncture. The treatment was conducted for four weeks, three sessions weekly for 12 sessions

Other: ElectroacupunctureOther: Conventional physical therapy program

Group B

EXPERIMENTAL

Consisted of 20 cases who received the same selected physical therapy program only, for four weeks, three sessions weekly for 12 sessions.

Other: Conventional physical therapy program

Interventions

Sterile, single-use stainless-steel acupuncture needles (0.25 × 30 mm) were inserted at six acupoints on the affected side: TE14., SI9., and GB21(shoulder region); LI11 and TE5 (elbow and forearm); and TE2 (dorsum of the hand)

Group A

(1) passive and active-assisted range of motion exercises (5-10 repetitions per movement, 10-15 second holds) (2) desensitization techniques using graded textures (cotton, sponge, Velcro, toothbrush), progressing from light touch to deep pressure, combined with contrast baths (3) therapeutic exercises, beginning with isometric strengthening and progressing to isotonic exercises as tolerated, followed by functional task-based activities targeting coordination and strength; (4) a structured stress-loading program involving active movement and joint compression, including quadruped scrubbing with the affected hand (5) heat therapy using hot packs for pain relief and (6) graded motor imagery, progressing through laterality training, explicit motor imagery, and mirror visual feedback. Each session began with a 5-minute warm-up and ended with a 5-minute cool-down.

Group AGroup B

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients were diagnosed clinically and referred from a neurologist
  • The study included cases who were 45 years old or more
  • Ischemic stroke at least six months following the stroke, were receiving treatment at the outpatient clinic, and demonstrated satisfactory cognitive function (Montreal Cognitive Assessment score of more than 26), spasticity of the limbs ranging from grade 1+ (2) on a modified Ashworth scale, and a confirmed diagnosis of CRPS by clinical assessment by a neurologist using the Budapest criteria for diagnosis of CRPS.
  • Unilateral upper-limb or shoulder pain persisting for at least four weeks and up to six months following the onset of stroke. Pain intensity rated ≥ 4/10 on the Visual Analogue Scale (VAS) at rest or with active/passive shoulder movement.

You may not qualify if:

  • Patients with current history of hand troubles and shoulder dysfunction before developing a stroke.
  • Patients with overactive sympathetic system from other causes e.g. congestive heart failure, impaired kidney functions.
  • Patients with significant musculoskeletal disorders which include rheumatoid arthritis or metabolic disorders comprising diabetes, Patients with cognitive impairments, Visual, auditory and speech problems and Patients with psychiatric disorders or seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

Location

MeSH Terms

Conditions

StrokeComplex Regional Pain Syndromes

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAutonomic Nervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Neurology and its Surgery Faculty of Physical Therapy - Al Ryada University for Science and Technology

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 9, 2026

Study Start

January 5, 2026

Primary Completion

July 12, 2026

Study Completion

August 24, 2026

Last Updated

October 9, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations