Manual Therapy on Activation of the Descending Pain Inhibitory System in Patients With Knee Osteoarthritis

NCT04256135 | Completed

• 1 other identifier: 0902201803618
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Knee osteoarthritis is a clinical syndrome which is characterized by pain. It has been shown to cause changes in the nervous system leading to central sensitization. There are factors involved in this disease such as sex (female) or obesity. The most recommended therapy is physical therapy, but manual therapy is needed to cause changes in central sensitization. Methods: Experimental, prospective, parallel and longitudinal double-blind study, in which two groups are performed: group A (AP mobilizations) and group B (Mulligan's mobilizations). Different variables and questionnaires were used: pressure pain threshold, temporal summation, pain modulation, central sensitization inventory, WOMAC, Times Up \& GO, numerical rating scale, Beck, STAI, kinesiophobia, catastrophism, Barthel and mini- cognitive test

Conditions

Musculoskeletal Manipulations; Osteoarthritis, Knee

Keywords

Mulligan mobilization; Maitland mobilization; Manual therapy

Outcome Measures

Primary Outcomes (3)

• Changes in Mechanical Hyperalgesia

  To measure the pain thresholds by pressure we use an algometer with a surface area of 1cm2 applying it perpendicularly to the skin with a speed of 1 kg / cm2 / s until the patient indicates that the first sensation of pain appears, ceasing at that moment the pressure made. Three measurements will be recorded with an interval of 30 seconds to avoid a temporal sum effect. The measurement will be taken in a distal region of the ipsilateral carpal long radial extender (a point distal to the carpal long radial extender (5cm distal to the lateral epicondyle)) and in the peripatellar region the standard UDP assessment protocol will be used. In the patellar region two sites will be evaluated (3cm medial and lateral to the midpoint of the lateral and medial patella border). A minimum change of 1.62-1.53 kg / cm2 is required for the result to be clinically significant.

  Change from Baseline Mechanical Hyperalgesia at 4th sessions

• Changes in Temporal Summation

  First the pressure pain thresholds are measured in the lateral area to the patella. Then 10 consecutive pulses are performed in the same locations to provoke the temporal sum, increasing the pressure by 2kg/s and maintaining it for 1 second (followed by 1 second of rest) in each pulse. The intensity of the pain is evaluated at the 1st, 5th and 10th pulse, by means of a numerical scale of the pain (0 being painless and 10 being the maximum pain imaginable).

  Change from Baseline Mechanical Hyperalgesia at 4th sessions

• Changes in Conditioned pain modulation

  First, pressure pain stimulus (test stimulus) will be conducted in the lateral area to the patella. Second, occlusion cuff will be inflated around the arm of patient until the patient feeling a painful intensity (conditioned stimulus) of 6/10. Finally, after 30 seconds the stimulus will be done. The difference in the mean value of the initial algometry with the mean value of algometry during the conditioning stimulus will indicate the state of the descending pain inhibitory system.

  Change from Baseline Mechanical Hyperalgesia at 4th sessions

Secondary Outcomes (10)

• Central sensitization inventory

  Baseline

• WOMAC Questionnaire

  Baseline

• Test Time Up & Go

  Change from Baseline Mechanical Hyperalgesia at 1 month

• Numerical rating scale (NRS)

  Change from Baseline Mechanical Hyperalgesia at 4th sessions

• Beck Depression Inventory (BDI)

  Baseline

Study Arms (2)

Experimental mobilization: Mulligan

EXPERIMENTAL

Mobilization will be performed while the patient actively performs knee flexion and/or extension depending on the patient's painful or limited movements. Three series of ten repetitions will be performed.

Other: Mulligan mobilization

Control mobilization: AP Maitland

ACTIVE COMPARATOR

The joint mobilization, will be carried out in the knee with both hands, with displacement of the tibia from the front to the back of the femur in an oscillatory way without pain, will be carried out in blocks of 2 minutes with rests of 30 seconds with a duration of about 6 minutes.

Other: AP Maitland mobilization

Interventions

Mulligan mobilization OTHER

Mobilization will be performed while the patient actively performs knee flexion and/or extension depending on the patient's painful or limited movements. Three series of ten repetitions will be performed.

Experimental mobilization: Mulligan

AP Maitland mobilization OTHER

The joint mobilization, will be carried out in the knee with both hands, with displacement of the tibia from the front to the back of the femur in an oscillatory way without pain, will be carried out in blocks of 2 minutes with rests of 30 seconds with a duration of about 6 minutes.

Also known as: AP Mobilization

Control mobilization: AP Maitland

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Knee pain diagnosed with osteoarthritis of the knee using the criteria of the American College of Rheumatology
• Low or no response to pain medication for osteoarthritis knee pain.

You may not qualify if:

• Suffer from any disorder, syndrome or disease that may cause myofascial or neuropathic pain in the lower limbs, such as lumbar radiculopathy, meralgia paresthetica or saphenous nerve entrapment.
• Infiltration with steroids or local anaesthetics during the year prior to the patient's participation in the study or during follow-up.
• History of previous lower extremity or lumbopelvic surgery.
• Ingestion of substances of abuse that may interfere with treatment.
• Contraindications to perform joint therapy mobilizations.
• Previous diagnosis of myopathy or neuropathy (lumbo-sacral plexus)
• Cognitive deficit manifested in the clinical history (Alzheimer, dementia).

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Josué Fernández Carnero, Phd

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Model Details: It is an experimental, prospective, parallel and longitudinal double-blind study with elderly patients with knee osteoarthritis

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: April 30, 2020
• Primary Completion: May 15, 2020
• Study Completion: June 10, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

ES (1)