Clinical trial NCT05085236: Fu's Subcutaneous Needling Treatment for Hemiplegic Shoulder Pain
Official title: Therapeutic Effect of Fu's Subcutaneous Needling for Recovery Outcomes of Stroke Survivors With Hemiplegic Shoulder Pain.: Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Keywords: Fu's subcutaneous needling
post-stroke complications
post-stroke shoulder pain
hemiplegic shoulder pain
shoulder hand syndrome
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The post-stroke survivors suffered from shoulder pain are very common. The investigators performed Fu's subcutaneous needling (FSN). This experiment used a randomized controlled trial to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling therapy on hemiplegic shoulder pain in patient with stroke.

Detailed description: The prevalence of complication in post-stroke survivors is 30-96%. Post-stroke pain is the most common complication. According to previous researches there are sixty percent post-stroke survivors who suffered from upper limb pain. The mechanism causes post-stroke shoulder pain is imbalance of shoulder muscles and in-coordination of shoulder motor control due to cerebral vascular disease. Post-stroke shoulder pain often causes the limitation of shoulder range of motion, and the pain always affected quality of life and daily activities. Because of shoulder pain, those post-stroke survivors postponed the program of rehabilitation. The treatments of post-stroke shoulder pain are transcutaneous electrical nerve stimulation, drug, intra-articular injection and nerve block. Acupuncture with combination of rehabilitation has been proved by many researches in alleviating pain and increasing quality of life in treating post-stroke shoulder pain. Fu's subcutaneous needling is a newly technique based on meridian theory and the technique is used to treat cervical, lumbar and four limb's pain proved by many researches. Fu's subcutaneous needling in managing post-stroke pain has less reported, so investigator set up a proposal to see if the Fu's subcutaneous needling could elevate more therapeutic effect compared to usual care or not.

The investigators will enroll patients into two groups, experimental and control groups. The interventions in experimental group are Fu's subcutaneous needling in combination with rehabilitation, and in control group is rehabilitation. The trial will extend two weeks, and investigator will treat with Fu's subcutaneous needling three times in the first, second and fourth day when the patients include to our trial. The outcome measurements are visual analog scale, range of motion of shoulder, pressure pain threshold of myofascial trigger point, acromion-greater tuberosity distance, Fugl-Meyer assessment in upper extremity and functional independence measure.

Eligibility criteria: Inclusion Criteria:

* 1. Volunteers who are older than 40 years old suffered from first stroke attack including infarction and hemorrhage with image proved and can cooperate with the experiment.
* 2. Stroke patient suffered from shoulder pain.
* 3. Patient can follow the directions of Fu's subcutaneous needling and regular rehabilitation program.

Exclusion Criteria:

* 1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant and lactated women.
* 2. There has been a history of drug abuse (including excess alcohol) that affects pain assessment.
* 3. Cognitive impairment, unable to cooperate with the experiment.
* 4. Aphasia
* 5. Have received shoulder joint injection in recent 6 months.
* 6. Have serious skin infection, laceration, wound and trauma.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1 day
measure: Pressure Pain Threshold
timeFrame: 1 day
measure: Range of Motion of Shoulder
timeFrame: 1 day
measure: Acromion-GreaterTuberosity Distance
timeFrame: 1 day
measure: Fugl-Meyer assessment in upper extremity
timeFrame: 1 day
measure: Functional Independence Measure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Li-Wei Chou, PhD
role: PRINCIPAL_INVESTIGATOR
References: