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Exercise and Pain Sensitivity

Primary Purpose

Knee Pain

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Knee muscle strengthening exercises
Upper extremity strengthening exercises
Cardiovascular fitness exercises
Sponsored by
Henning Bliddal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Pain

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Parker Institute, Frederiksberg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

Knee muscle strengthening exercises

Upper extremity strengthening exercises

Cardiovascular fitness exercises

Arm Description

No intervention for 12 weeks

Outcomes

Primary Outcome Measures

Change in pressure pain sensitivity

Secondary Outcome Measures

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

Full Information

First Posted
May 9, 2011
Last Updated
October 4, 2012
Sponsor
Henning Bliddal
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1. Study Identification

Unique Protocol Identification Number
NCT01351558
Brief Title
Exercise and Pain Sensitivity
Official Title
Exercise and Alterations in Pain Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties.
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henning Bliddal

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention for 12 weeks
Arm Title
Knee muscle strengthening exercises
Arm Type
Active Comparator
Arm Title
Upper extremity strengthening exercises
Arm Type
Active Comparator
Arm Title
Cardiovascular fitness exercises
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Knee muscle strengthening exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Upper extremity strengthening exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cardiovascular fitness exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in pressure pain sensitivity
Time Frame
Baseline, and after 12 weeks of exercise
Secondary Outcome Measure Information:
Title
Change in muscle strength
Description
Muscle strength is measured in knee extension and flexion and in arm extension and flexion (bench press and pull)
Time Frame
baseline and after 12 weeks
Title
Change in cardiovascular fitness
Description
Watt max test is performed on a bicycle ergometer to estimate the maximal oxygen uptake velocity
Time Frame
baseline after 4 weeks and after 12 weeks
Title
Change in baroreflex sensitivity
Description
Heart rate and blood pressure variability is measured during rest and during quiet standing.
Time Frame
baseline after 4 weeks and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Henriksen, PT,PhD
Organizational Affiliation
Senior Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Institute, Frederiksberg University Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24167727
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.
Results Reference
derived

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Exercise and Pain Sensitivity

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