Effects of Low Frequency TENS and Therapeutic Ultrasound in Post-stroke Shoulder Pain

NCT05931185 | Unknown

• 1 other identifier: REC/RCR & AHS/23/0201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Post-Stroke shoulder pain is a well-known complication and is responsible for the reduction in functional outcomes. A number of factors related to post-stroke shoulder pain including shoulder activity limitation, spasticity of shoulder muscles, and shoulder subluxation. Stroke patients may suffer from pain caused by the stroke itself (central post-stroke pain). Physical therapy plays an important role in the management of post-stroke shoulder pain. Different physical therapy techniques and modalities have been used in reducing pain and increasing functional outcomes in post-stroke shoulder pain patients. This study aims to provide a combined analysis of two modalities: low-frequency TENS and Therapeutic Ultrasound in terms of effects on pain and functional disability. This will be a randomized clinical trial to determine the analgesic effect of low-frequency transcutaneous electrical stimulation and therapeutic ultrasound on functional disability in post-stroke shoulder pain. The study will be conducted in accordance with ethical guidelines of Riphah International University and a convenience sampling technique will be used. Patients aged 65-84 years, with a history of pain of more than 4 weeks will be included in our study. Patients having a stroke with other neurological deficits, unstable cardiovascular diseases such as ventricular arrhythmias, and stroke patients with a history of diagnosed frozen shoulder will be excluded from the study. Subjects will be randomly allocated into three groups. Baseline assessment of pain and functional disability of patients will be done using outcome measuring tools and clinical tests. Group A will receive low-frequency TENS and therapeutic Ultrasound as a treatment, group B will receive therapeutic ultrasound and Group C will receive low-frequency TENS as a treatment. The duration of the study will be six weeks and patients will receive a total of 12 treatment sessions (3 sessions per week for 4 weeks and then follow-up will be done for the next 2 weeks) and the duration of each session will be of 20-25 minutes. After 12 sessions, a final assessment will be done and the results will be analyzed. Frequencies and mean standard deviation will be measured, and parametric and non-parametric tests will be applied.

Conditions

Stroke; Shoulder Pain

Keywords

Post-Stroke shoulder pain; Low frequency TENS; Therapeutic ultrasound; Functional disability

Outcome Measures

Primary Outcomes (3)

• .Numerical Pain Rating Scale

  We used an 11-point numerical pain rating scale. (Where 0 = no pain; 10 = maximum pain) to assess the intensity of spontaneous HSP. The patients were required not to take analgesics or muscle relaxants for 24 h prior to the assessment

  6 weeks

• Shoulder Pain and Disability Index

  shoulder pain and disability index is a 13 items subjective questionnaire. Which is used to measure the level of pain and disability associated with shoulder pathologies. It has two subsets: Pain (5 items) and disability (8 items) to assess functional status of individuals with shoulder problems

  6 weeks

• Disabilities of Arm, Shoulder Hand questionnaire

  The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self- report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time

  6 weeks

Study Arms (3)

Low frequency transcutaneous electrical stimulation and Therapeutic Ultrasound

EXPERIMENTAL

participant will receive low frequency transcutaneous electrical stimulation and therapeutic Ultrasound as a treatment

Other: low frequency transcutaneous electrical stimulation and Therapeutic Ultrasound

Therapeutic Ultrasound

ACTIVE COMPARATOR

patients will receive therapeutic ultrasound as a treatment

Other: Therapeutic Ultrasound

Low frequency transcutaneous electrical stimulation

ACTIVE COMPARATOR

participant will receive low frequency transcutaneous electrical stimulation

Other: Low frequency transcutaneous electrical stimulation

Interventions

low frequency transcutaneous electrical stimulation and Therapeutic Ultrasound OTHER

patients will receive low-frequency transcutaneous electrical stimulation for 15 minutes and therapeutic Ultrasound for 10 minutes as a treatment and patients will receive a total of 12 treatment sessions (3 sessions per week for 4 weeks and then follow-up will be done for the next 2 weeks) and the total duration of each session will be of 25 minutes.

Low frequency transcutaneous electrical stimulation and Therapeutic Ultrasound

Therapeutic Ultrasound OTHER

patients will receive a therapeutic ultrasound for 10 minutes three times a week for 4 weeks and then follow-up will be done for the next 2 weeks

Therapeutic Ultrasound

Low frequency transcutaneous electrical stimulation OTHER

participants will receive low-frequency transcutaneous electrical stimulation for 15 minutes three times a week for 4 weeks and then follow-up will be done for the next 2 weeks

Low frequency transcutaneous electrical stimulation

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-84 years(23)
• Both genders male and female will be included
• Ischemic and hemorrhagic both types of strokes will be included
• Patients with a history of shoulder pain

You may not qualify if:

• Patients with another neurological disease
• Patients with unstable cardiovascular disease such as ventricular arrhythmias
• Patients with a history of traumatic brain injury Patients with a history of traumatic brain injury
• Any contraindications for UST or TENS therapy

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

RECRUITING

Related Publications (11)

• Broeks JG, Lankhorst GJ, Rumping K, Prevo AJ. The long-term outcome of arm function after stroke: results of a follow-up study. Disabil Rehabil. 1999 Aug;21(8):357-64. doi: 10.1080/096382899297459.

  PMID: 10503976 BACKGROUND

• Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.

  PMID: 17185637 BACKGROUND

• Eslamian F, Farhoudi M, Jahanjoo F, Sadeghi-Hokmabadi E, Darabi P. Electrical interferential current stimulation versus electrical acupuncture in management of hemiplegic shoulder pain and disability following ischemic stroke-a randomized clinical trial. Arch Physiother. 2020 Jan 10;10:2. doi: 10.1186/s40945-019-0071-6. eCollection 2020.

  PMID: 31938571 BACKGROUND

• Dyer S, Mordaunt DA, Adey-Wakeling Z. Interventions for Post-Stroke Shoulder Pain: An Overview of Systematic Reviews. Int J Gen Med. 2020 Dec 7;13:1411-1426. doi: 10.2147/IJGM.S200929. eCollection 2020.

  PMID: 33324087 BACKGROUND

• Walsh K. Management of shoulder pain in patients with stroke. Postgrad Med J. 2001 Oct;77(912):645-9. doi: 10.1136/pmj.77.912.645.

  PMID: 11571371 BACKGROUND

• Griffin JW. Hemiplegic shoulder pain. Phys Ther. 1986 Dec;66(12):1884-93. doi: 10.1093/ptj/66.12.1884.

  PMID: 2431421 BACKGROUND

• Ekim A, Armagan O, Oner C. [Efficiency of TENS treatment in hemiplegic shoulder pain: a placebo controlled study]. Agri. 2008 Jan;20(1):41-6. Turkish.

  PMID: 18338278 BACKGROUND

• Vecchio P, Cave M, King V, Adebajo AO, Smith M, Hazleman BL. A double-blind study of the effectiveness of low level laser treatment of rotator cuff tendinitis. Br J Rheumatol. 1993 Aug;32(8):740-2. doi: 10.1093/rheumatology/32.8.740.

  PMID: 8348278 BACKGROUND

• Vlak T, Jakelic K, Jajic I. [Comparative study of the effectiveness of lasers and cryotherapy in the treatment of painful shoulder syndrome]. Reumatizam. 1994;41(1):9-15. Croatian.

  PMID: 7638444 BACKGROUND

• Celik EC, Erhan B, Gunduz B, Lakse E. The effect of low-frequency TENS in the treatment of neuropathic pain in patients with spinal cord injury. Spinal Cord. 2013 Apr;51(4):334-7. doi: 10.1038/sc.2012.159. Epub 2013 Jan 8.

  PMID: 23295472 BACKGROUND

• van der Windt DAWM, van der Heijden GJMG, van den Berg SGM, Ter Riet G, de Winter AF, Bouter LM. Ultrasound therapy for musculoskeletal disorders: a systematic review. Pain. 1999 Jun;81(3):257-271. doi: 10.1016/S0304-3959(99)00016-0.

  PMID: 10431713 BACKGROUND

MeSH Terms

Conditions

Stroke; Shoulder Pain

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• hira jabeen

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hira jabeen

CONTACT

03234116506; hira.jabeen@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: November 11, 2022
• Primary Completion: August 15, 2023
• Study Completion: October 1, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)