Exercise and Pain Sensitivity

Sponsor
Henning Bliddal (Other)
Overall Status
Terminated
CT.gov ID
NCT01351558
Collaborator
(none)
33
1
4
10
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Knee muscle strengthening exercises
  • Other: Upper extremity strengthening exercises
  • Other: Cardiovascular fitness exercises
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Exercise and Alterations in Pain Sensitivity
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Change in pressure pain sensitivity [Baseline, and after 12 weeks of exercise]

Secondary Outcome Measures

  1. 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)

  2. 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

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 The Parker Institute, Frederiksberg University Hospital Copenhagen Denmark

Sponsors and Collaborators

  • Henning Bliddal

Investigators

  • Principal Investigator: Marius Henriksen, PT,PhD, Senior Researcher

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01351558
Other Study ID Numbers:
  • 101.01
  • 10-093704
First Posted:
May 11, 2011
Last Update Posted:
Oct 5, 2012
Last Verified:
Oct 1, 2012
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2012