Transcutaneous Electrical Nerve Stimulation in Relation to Central Sensitization in Osteoarthritis of the Knee

NCT01390285 | Unknown

• 1 other identifier: Tenssens
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Central sensitization has recently been documented in patients with knee osteoarthritis. So far, the presence of central sensitization has not been considered as a confounding factor in studies assessing the pain inhibitory effect of TENS on osteoarthritis of the knee. Purpose First, to explore the pain inhibitory effect of burst TENS in OAk patients. Second, to explore the prognostic value of central sensitization on the pain inhibitory effect of TENS in Oak patients. Methods Patients with knee pain due to OAk will be recruited through advertisements in local media. Temporal summation, before and after a heterotopic noxious conditioning stimulation, will be measured. In addition, pain on a numeric rating score and WOMAC subscores for pain and function will be assessed. Patients will be randomly allocated to one of two treatment groups (TENS, sham TENS). Follow-up measurements will be scheduled after a period of 6 and 12 weeks. Discussion/ conclusion TENS influences pain through the electrical stimulation of low-threshold A-beta cutaneous fibers. The responsiveness of central pain-signaling neurons of OAk patients who are centrally sensitized may be augmented to the input of these electrical stimuli. This would encompass an adverse therapy effect of TENS. Therefore it might be interesting to identify a subgroup of symptomatic OAk patients, ie. non-sensitized patients, who are likely to benefit from burst TENS.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Overall average knee pain

  numeric rating score

  after 6 and 12 weeks

Secondary Outcomes (2)

• Change from baseline in self reported knee pain and difficulty with physical function (WOMAC)

  baseline - 6 weeks

• Change from baseline in self reported knee pain and difficulty with physical function (WOMAC)

  baseline - 12 weeks

Study Arms (2)

TENS

EXPERIMENTAL

Device: Transcutaneous electric nerve stimulation

Sham TENS

SHAM COMPARATOR

Device: sham transcutaneous electrical nerve stimulation

Interventions

Transcutaneous electric nerve stimulation DEVICE

The subjects that enter the TENS-group will be asked to apply the TENS therapy for at least 40 minutes continuously per day. The parameters of the current will not be changed during the study (pulse: 250 µsec; internal frequency: 100Hz; burst frequency 3 Hz; intensity: until an unpleasant but not painful sensation is acquired).

TENS

sham transcutaneous electrical nerve stimulation DEVICE

The patients that are assigned to the sham TENS will receive an inactive placebo TENS therapy using a nonfunctional unit that appears to work but provides no stimulus.

Sham TENS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included, patients need to be over 50 years old.
• All should have osteoarthritis in at least one knee fulfilling the American College of Rheumatology classification criteria and report peak knee pain over the last 24 h of more than 3 on a Numeric Rating Score (0-10 scale).

You may not qualify if:

• Patients are excluded if they have had a knee surgery or intra-articular corticosteroid injection within 6 months
• Current or past (within 4 weeks) oral corticosteroid use
• A history of knee joint replacement or tibial osteotomy
• Contraindications to burst TENS (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy) or if they are unable to apply TENS independently

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Related Publications (1)

• Beckwee D, De Hertogh W, Lievens P, Bautmans I, Vaes P. Effect of tens on pain in relation to central sensitization in patients with osteoarthritis of the knee: study protocol of a randomized controlled trial. Trials. 2012 Feb 21;13:21. doi: 10.1186/1745-6215-13-21.

  PMID: 22353582 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: July 11, 2011
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 11, 2011

Record last verified: 2011-04