Clinical trial NCT01351558: Exercise and Pain Sensitivity
Official title: Exercise and Alterations in Pain Sensitivity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Pain
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in pressure pain sensitivity
timeFrame: Baseline, and after 12 weeks of exercise
Secondary outcomes:
measure: Change in muscle strength
timeFrame: baseline and after 12 weeks
measure: Change in cardiovascular fitness
timeFrame: baseline after 4 weeks and after 12 weeks
measure: Change in baroreflex sensitivity
timeFrame: baseline after 4 weeks and after 12 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg University Hospital
Study officials:
affiliation: Senior Researcher
name: Marius Henriksen, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henriksen M, Klokker L, Bartholdy C, Graven-Nielsen T, Bliddal H. The Associations between Pain Sensitivity and Knee Muscle Strength in Healthy Volunteers: A Cross-Sectional Study. Pain Res Treat. 2013;2013:787054. doi: 10.1155/2013/787054. Epub 2013 Sep 17.