Exercise and Pain Sensitivity

Not Applicable

Terminated

• Conditions: Knee Pain
• Interventions: Other: Knee muscle strengthening exercises; Other: Cardiovascular fitness exercises; Other: Upper extremity strengthening exercises

• Registration Number: NCT01351558
• Lead Sponsor: Henning Bliddal

Brief Summary

There is ample evidence that exercise therapy is beneficial with respect to pain in patients with osteoarthritis of the knee. However, the pain relieving mechanisms are unknown. To enhance the efficacy of exercise therapy a deeper understanding of the involved mechanisms is needed.

Different exercise types may affect the pain sensitivity differently. It is hypothesized that non-specific exercises (i.e. exercises that does not involve the knee) reduces the processing of pain in the central nervous system (central sensitivity) to knee joint pain in healthy subjects. It is also hypothesized that exercises that involve the knee (i.e. specific knee exercises) reduce the sensitivity of pain receptors in the knee (peripheral sensitivity) in healthy subjects.

Healthy volunteers are recruited and randomised to one of four interventions: 1: Muscle strengthening exercises involving the thigh muscles; 2: Muscle strengthening exercises involving the shoulder muscles; 3: Cardio-vascular fitness exercises; or 4: Control (no exercises). The active interventions include exercises three times per week for 12 weeks. Pain sensitivity and a range of explanatory variables is measured before the interventions, after 4 weeks and after 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-11
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-04
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Age between 18 and 35 years
• Untrained (i.e. less than 2 hours of organised exercise per week in the last 6 months - physical activity related to transportation (e.g. bicycling) is not included)
• Generally healthy according a medical exam at screening, history
• Willing and able to participate in all measurements
• Willing and able to attend all training sessions
• Willing to keep the habitual activity and amount of training constant (ie screening activity and training volume).
• 20 ≤ body mass index (BMI) ≤ 28 kg/m2
• Speak, read and write Danish

Exclusion Criteria

• Pregnant or breastfeeding
• Current or previous symptoms of autoimmune disease (eg, inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis)
• Planned surgery during the study period
• Current or former musculoskeletal injuries or illnesses, including but not confined to:
• Ligament Injuries
• Meniscus Injuries
• Osteoarthritis
• Patellofemoral Pain Syndrome
• Backache
• Neck pain
• tendinopathy
• Current or past diagnosis, signs or symptoms of significant cardiovascular disease, including but not limited to:
• Ischemic heart disease
• Arteriosclerosis
• Medical conditions that contraindicate exercise, including but not limited to:
• Chronic or congenital heart disease
• Asthma
• Chronic Obstructive Pulmonary Disease
• Past or current diagnosis, signs or symptoms of significant neurological disease, in-incl. but not limited to:
• Blood clot in brain
• Stroke
• Clinically significant head trauma within the last year
• Peripheral neuropathy
• Epilepsy or seizures
• Impaired balance
• Alcohol or drug abuse within the past 5 years
• Past or current diagnosis, signs or symptoms of major psychiatric disorder
• Regional pain syndromes like fibromyalgia
• Regional pain caused by lumbar nerve root or cervical radiculopathy with or at risk for developing it

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Knee muscle strengthening exercises	Knee muscle strengthening exercises	-
Cardiovascular fitness exercises	Cardiovascular fitness exercises	-
Upper extremity strengthening exercises	Upper extremity strengthening exercises	-

Primary Outcome Measures

Name	Time	Method
Change in pressure pain sensitivity	Baseline, and after 12 weeks of exercise

Secondary Outcome Measures

Name	Time	Method
Change in muscle strength	baseline and after 12 weeks	Muscle strength is measured in knee extension and flexion and in arm extension and flexion (bench press and pull)
Change in cardiovascular fitness	baseline after 4 weeks and after 12 weeks	Watt max test is performed on a bicycle ergometer to estimate the maximal oxygen uptake velocity
Change in baroreflex sensitivity	baseline after 4 weeks and after 12 weeks	Heart rate and blood pressure variability is measured during rest and during quiet standing.

Trial Locations

Locations (1)

The Parker Institute, Frederiksberg University Hospital; 🇩🇰 Copenhagen, Denmark