Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain

NCT06428851 | Completed

• 1 other identifier: 2023-174
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate whether laser and neuromuscular electrical nerve stimulation applied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other.

Conditions

Hemiplegic Shoulder Pain

Keywords

hemiplegic shoulder pain; electrical nerve stimulation; laser

Outcome Measures

Primary Outcomes (1)

• Pain Level

  The pain level of the patients will be measured with a scale given to the patient; visual pain scale. Patients rate their pain on a scale of 0-10. It consists of scores ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate more severe pain.

  baseline and through study completion, an average of 4 weeks

Secondary Outcomes (5)

• upper extremity functions

  baseline and through study completion, an average of 4 weeks

• Disability

  baseline and through study completion, an average of 4 weeks

• Daily living activities

  baseline and through study completion, an average of 4 weeks

• Spasticity

  baseline and through study completion, an average of 4 weeks

• Recovery Stage

  baseline and through study completion, an average of 4 weeks

Study Arms (3)

Laser therapy Group

ACTIVE COMPARATOR

Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. Group 1 Laser therapy group (n:25) in addition to classical physical therapy, laser was applied to the shoulder group muscles for 5 minutes a day, 3 days a week for 4 weeks.

Other: Laser therapy

Neuromuscular electrical nerve stimulation Group

ACTIVE COMPARATOR

Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. In Neuromuscular electrical nerve stimulation group, in addition to these exercises, Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscle groups for 20 minutes a day, 5 days a week for a total of 4 weeks.

Other: Neuromuscular electrical nerve stimulation

Control Group

ACTIVE COMPARATOR

Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises.

Other: Control

Interventions

Laser therapy OTHER

Shoulder girdle muscles were lasered for 5 minutes a day, 3 days a week, total of 4 weeks.

Laser therapy Group

Neuromuscular electrical nerve stimulation OTHER

Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscles for 20 minutes a day 5 days a week, total of 4 weeks.

Neuromuscular electrical nerve stimulation Group

Control OTHER

Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises 5 days a week for 1 hour, total of 4 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with unilateral ischemic stroke for the first time
• years old,
• patients with shoulder pain

You may not qualify if:

• another disease that will affect the central nervous system
• injections or physical therapy to the same shoulder in the last 3 months,
• history of shoulder surgery,
• cervical radiculopathy,
• inflammatory rheumatic disease or infection,
• serious cardiovascular disease such as heart failure, arrhythmia, myocardial infarction that will affect functional status,
• disease that will cause cognitive dysfunction,
• Alzheimer's disease, dementia,
• severe visual loss,
• pregnancy and lactation,
• malignancy,
• psychiatric diseases

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University

Çorum, 19040, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• MUSTAFA KESER, Ass Prof

  HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants: stroke patients with shoulder pain Care provider: physiotherapist who applied the treatments to the patients Investigator: Researchers who were blinded to the treatment groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1. Laser therapy 2. Neuromuscular electrical nerve stimulation therapy (NMES) 3. Control: classical physical therapy exercises 3\)

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 24, 2024
• Study Start: December 26, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

TU (1)