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Clinical Trials/NCT02698072
NCT02698072
Completed
Not Applicable

Improvement in Pain and Function Following a Therapeutic Exercise Program and Dry Needling in Older Adults With Knee Osteoarthritis: A Randomized Double-blind Multicenter Controlled Clinical Trial

Universidad Rey Juan Carlos1 site in 1 country100 target enrollmentMarch 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Universidad Rey Juan Carlos
Enrollment
100
Locations
1
Primary Endpoint
Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study evaluates the combination of a therapeutic exercise program and dry needling in the treatment of knee osteoarthritis in older adults. Half of participants will receive therapeutic exercise program and dry needling in combination, while the other half will receive the same therapeutic exercise program and sham dry needling.

Detailed Description

Therapeutic exercise and dry needling each relieve pain and improve function, but they are different treatment tools. Therapeutic exercise takes a multitude of forms and results in numerous systemic and local effects, some of which have been investigate among people with knee osteoarthritis. Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of this therapeutic approach is to improve muscle strength, given that weakness is common in knee osteoarthritis. Enhanced strength of the lower limb may lessen internal knee forces, reduce pain and improve physical function. Primary knee osteoarthritis provokes pain and disfunction is thought mediated by joint damage and changes in joint homeostasis. Recently, investigations focused in impaired neuromuscular system as a contribution to the above mentioned symptoms in the knee osteoarthritis syndrome explore the use of dry needling. Dry needling is a therapeutic approach for decreasing pain and improve function with high recommended evidence (grade A) effectiveness for upper-quarter myofascial pain, but poorly understood in knee osteoarthritis patients.

Registry
clinicaltrials.gov
Start Date
March 15, 2016
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Josue Fernandez Carnero

PhD

Universidad Rey Juan Carlos

Eligibility Criteria

Inclusion Criteria

  • Participants aged 62 years and older.
  • Unilateral or bilateral disfunction and/or knee pain.
  • Primary knee ostearthritis fulfilling the American College of Rheumatology criteria for clinical and radiographic diagnostic.
  • At least 1 pain point elicited by palpation ipsilateral to the painful knee situated in a taut band of a skeletal muscle of the lower limbs, which usually have referred pain.

Exclusion Criteria

  • Prior diagnoses or prescriptions in the medical record for myopathy or lumbo-sacral neuropathy.
  • Previous knee or hip joint replacement surgery of the affected joint.
  • Any other surgical procedure of the lower limbs in the previous 6 months.
  • Rheumatoid arthritis.
  • Initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within the previous 30 days.
  • Alcohol or drugs consumption.
  • Uncontrolled hypertension or moderate to high risk for cardiac complications during exercise.
  • Conservative or invasive physical therapy (previous 6 months or during follow-up).
  • Taking antiaggregant or anticoagulant medications.
  • Physical impairments unrelated to the hip or knee preventing safe participation in exercise, walking or stationary cycling, such as: vision problems that affect mobility, body weight greater than 155 kg, neurogenic disorder, primary or significantly limiting back pain, advanced osteoporosis, or inability to walk 10 metres without an assistive device.

Outcomes

Primary Outcomes

Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.

Time Frame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up

The disease-specific questionnaire WOMAC is the most widely used instrument created and validated to evaluate both the symptomatology and function on osteoarthritis of the hip or knee.

Secondary Outcomes

  • Mini-Mental State Examination (MMSE)(Base line and 12 months follow-up)
  • The Timed Up & Go Test(Base line, through study completion (3 months); and 3, 6 and 12 months follow-up)
  • EuroQol-5(Base line, through study completion (3 months); and 3, 6 and 12 months follow-up)
  • Barthel Index(Base line, through study completion (3 months); and 3, 6 and 12 months follow-up)
  • Numeric Pain Rating Scale (NPRS)(Base line, through study completion (3 months); ; and 3, 6 and 12 months follow-up)

Study Sites (1)

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