Trial record 2 of 11 for:    Reduce-It

Exercise and Post-dry Needling Soreness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier:
NCT02558686
First received: September 21, 2015
Last updated: January 20, 2016
Last verified: January 2016
  Purpose
Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated.

Condition Intervention
Shoulder Pain
Other: Eccentric Exercise
Other: Detuned Ultrasound
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Eccentric Exercise, Sham or Placebo on Post-Needling Soreness by Dry Needling on Active Trigger Points

Resource links provided by NLM:


Further study details as provided by Universidad Rey Juan Carlos:

Primary Outcome Measures:
  • Changes in post-dry needling pain intensity before and after the intervention [ Time Frame: Baseline, 24 hours after, 48 hours after and 72 hours after treatment ] [ Designated as safety issue: Yes ]
    A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain


Secondary Outcome Measures:
  • Changes in spontaneous shoulder pain before and after the intervention [ Time Frame: Baseline and 72 hours after treatment ] [ Designated as safety issue: Yes ]
    A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain

  • Changes in disability before and after the intervention [ Time Frame: Baseline and 72 hours after treatment ] [ Designated as safety issue: Yes ]
    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess disability induced by shoulder pain.

  • Changes in functionality before and after the intervention [ Time Frame: Baseline and 72 hours after treatment ] [ Designated as safety issue: Yes ]
    The Shoulder Pain and Disability Index (SPADI) questionnaire will be used to assess function of the uppr extremity related to shoulder pain


Enrollment: 90
Study Start Date: October 2015
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eccentric Exercise
Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling
Other: Eccentric Exercise
Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling
Sham Comparator: Detuned Ultrasound
Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling
Other: Detuned Ultrasound
Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling
Placebo Comparator: Placebo
Individuals will not perform any action after the application of trigger point dry needling
Other: Placebo
Individuals will not perform any action after the application of trigger point dry needling

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral non-traumatic shoulder pain
  • Shoulder pain from at least 6 months
  • Shoulder pain of more than 3 points on a NPRS
  • Presence of active trigger point in the infraspinatus muscle

Exclusion Criteria:

  • bilateral shoulder pain
  • younger than 18 or older than 65 years
  • shoulder injury
  • upper extremity surgery
  • fibromyalgia syndrome
  • neck or shoulder surgery
  • cervical radiculopathy
  • whiplash
  • any type of intervention for the neck-shoulder the previous year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02558686

Locations
Spain
Universidad Rey Juan Carlos
Alcorcon, Madrid, Spain, 28922
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
Principal Investigator: Cesar Fernández-de-las-Peñas, PhD Universidad Rey Juan Carlos
  More Information

Responsible Party: César Fernández-de-las-Peñas, Head Division, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02558686     History of Changes
Other Study ID Numbers: URJC 2015-12 
Study First Received: September 21, 2015
Last Updated: January 20, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Rey Juan Carlos:
trigger points
disability
post-dry needling soreness
eccentric exercise

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 21, 2016