Exercise and Pain Sensitivity

NCT01351558 | Terminated

• 2 other identifiers: 101.0110-093704
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Pain

Outcome Measures

Primary Outcomes (1)

• Change in pressure pain sensitivity

  Baseline, and after 12 weeks of exercise

Secondary Outcomes (3)

• Change in muscle strength

  baseline and after 12 weeks

• Change in cardiovascular fitness

  baseline after 4 weeks and after 12 weeks

• Change in baroreflex sensitivity

  baseline after 4 weeks and after 12 weeks

Study Arms (4)

Control

NO INTERVENTION

No intervention for 12 weeks

Knee muscle strengthening exercises

ACTIVE COMPARATOR

Other: Knee muscle strengthening exercises

Upper extremity strengthening exercises

ACTIVE COMPARATOR

Other: Upper extremity strengthening exercises

Cardiovascular fitness exercises

ACTIVE COMPARATOR

Other: Cardiovascular fitness exercises

Interventions

Knee muscle strengthening exercises OTHER

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

Knee muscle strengthening exercises

Upper extremity strengthening exercises OTHER

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

Upper extremity strengthening exercises

Cardiovascular fitness exercises OTHER

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

Cardiovascular fitness exercises

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• ≤ body mass index (BMI) ≤ 28 kg/m2
• Speak, read and write Danish

You may not qualify if:

• 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:

Sponsors & Collaborators

• Henning Bliddal: lead

Study Sites (1)

The Parker Institute, Frederiksberg University Hospital

Copenhagen, Denmark

Location

Related Publications (1)

• 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.

  PMID: 24167727 DERIVED

Study Officials

• Marius Henriksen, PT,PhD

  Senior Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 11, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 5, 2012

Record last verified: 2012-10

Locations

DK (1)