Exercise and Pain Sensitivity

October 4, 2012 updated by: Henning Bliddal

Exercise and Alterations in Pain Sensitivity

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark
        • The Parker Institute, Frederiksberg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention for 12 weeks
Active Comparator: 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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pressure pain sensitivity
Time Frame: Baseline, and after 12 weeks of exercise
Baseline, and after 12 weeks of exercise

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Estimate)

October 5, 2012

Last Update Submitted That Met QC Criteria

October 4, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101.01
  • 10-093704 (Other Grant/Funding Number: Danish Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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