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OpenTrials
Completed

NCT Number: NCT03703193

Dry Needling for Shoulder Pain in Stroke Patients

Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. No previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

César Fernández-de-las-Peñas

Alcorcón, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first-ever unilateral stroke;
  • hemiplegia resulting from stroke;
  • age between 30 and 60 years old;
  • presence of hypertonicity in the upper extremity;
  • pain symptoms in the shoulder
  • active trigger points in the shoulder muscles reproducing the shoulder pain symptoms

Exclusion criteria

  • recurrent stroke;
  • absence of active trigger points in the shoulder muscles reproducing shoulder symptoms
  • previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
  • previous treatment with botulinum toxin-A in the 6 months prior the study;
  • severe cognitive deficits;
  • other neurologic diseases,
  • underlying complex medical conditions, e.g., heart conditions, unstable hypertension, fracture
  • fear to needles;
  • any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.

Treatment and study plan

dry needling

Other

A single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.

Physical Therapy

Other

A single session of modulatory interventions targeting modulation of central nervous system.

Primary outcomes

  1. Changes in post-dry needling pain intensity with a numerical pain rate scale before and after the intervention

    Time frame: Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment the intervention

    A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness in the targeted area

Secondary outcomes

  1. Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention

    Time frame: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention

    A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain

  2. Presence of active trigger points in the shoulder musculature

    Time frame: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention

    Manual palpation of active trigger points in the shoulder muscles will be conducted

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Dry Needling for Shoulder Pain and Presence of Post-needling Induced-Pain in PAtients Who Had Suffered a Stroke

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2018
Registry last updated
Dec 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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