Clinical trial NCT02698072: Improvement in Pain and Function Following a Physiotherapy Program in Older Adults With Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Stiffness
Pain
Disfunction
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Ilustre Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid
First posted: 2016-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 62
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* Inability to comprehend and complete study assessments or comply with study instructions.
* Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
* Fibromyalgia syndrome or other altered affective/cognitive modulation processes of pain perception. .

Primary outcomes:
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
timeFrame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Base line, through study completion (3 months); ; and 3, 6 and 12 months follow-up
measure: Barthel Index
timeFrame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
measure: The Timed Up & Go Test
timeFrame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
measure: Mini-Mental State Examination (MMSE)
timeFrame: Base line and 12 months follow-up
measure: EuroQol-5
timeFrame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Other outcomes:
measure: Total number of falls change assessment.
timeFrame: At Baseline and 1 year follow-up.
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Eleuterio Atanasio Sánchez Romero, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez Romero EA, Fernandez-Carnero J, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Pecos-Martin D. Is a Combination of Exercise and Dry Needling Effective for Knee OA? Pain Med. 2020 Feb 1;21(2):349-363. doi: 10.1093/pm/pnz036.