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Exercise and Pain Sensitivity

This study has been terminated.
(Recruitment difficulties.)
Sponsor:
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01351558
First received: May 9, 2011
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Knee Pain
 Other: Knee muscle strengthening exercises
Other: Upper extremity strengthening exercises
Other: Cardiovascular fitness exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exercise and Alterations in Pain Sensitivity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Change in pressure pain sensitivity [ Time Frame: Baseline, and after 12 weeks of exercise ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in muscle strength [ Time Frame: baseline and after 12 weeks ] [ Designated as safety issue: No ]
    Muscle strength is measured in knee extension and flexion and in arm extension and flexion (bench press and pull)

  • Change in cardiovascular fitness [ Time Frame: baseline after 4 weeks and after 12 weeks ] [ Designated as safety issue: No ]
    Watt max test is performed on a bicycle ergometer to estimate the maximal oxygen uptake velocity

  • Change in baroreflex sensitivity [ Time Frame: baseline after 4 weeks and after 12 weeks ] [ Designated as safety issue: No ]
    Heart rate and blood pressure variability is measured during rest and during quiet standing.


Enrollment: 33
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No intervention for 12 weeks
Active Comparator: Knee muscle strengthening exercises Other: Knee muscle strengthening exercises
Muscle strengthening exercises of the quadriceps and hamstring muscles will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
Active Comparator: Upper extremity strengthening exercises Other: Upper extremity strengthening exercises
Muscle strengthening exercises of the upper amrs and shoulder girdle will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
Active Comparator: Cardiovascular fitness exercises Other: Cardiovascular fitness exercises
Cardiovascular fitness exercises encompass circuit training including exercises on (but not limited to): ergometer cycles, treadmills (running), and cross-trainers. The exercise intensity is aiming at exercises within 60-85% of maximum heart rate (defined as 220 - age). The heart rate is monitored using a standard heart rate monitor. The exercises will be supervised

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351558

Locations
Denmark
The Parker Institute, Frederiksberg University Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Henning Bliddal
Investigators
Principal Investigator: Marius Henriksen, PT,PhD Senior Researcher
  More Information

No publications provided

Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01351558     History of Changes
Other Study ID Numbers: 101.01, 10-093704
Study First Received: May 9, 2011
Last Updated: October 4, 2012
Health Authority: Denmark: The Capital Region of Denmark

ClinicalTrials.gov processed this record on May 22, 2013