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Clinical Trials/NCT06415825
NCT06415825Not yet recruitingNot Applicable

Preliminary Muscle Contraction in the Rehabilitation and Prevention of Degenerative Pain in the Spine, Hip, Knee, Ankle, Shoulder, Elbow, and Ankle Joints, as Well as After Hip and Knee Arthroplasty

Medical University of Sofia0 sites216 target enrollmentStarted: May 14, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
216
Primary Endpoint
Visual analogue pain scale

Study Overview

Brief Summary

RESEARCH OBJECTIVE: To investigate the effect of muscle preliminary contraction in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. HYPOTHESIS: Muscle preliminary contraction has a significant short-term and long-term effect in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. RESEARCH METHODS: At least 216 patients with degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty, will be studied. They will be randomized into pairwise sub-groups. All will receive standard advice. The maneuver sub¬groups will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. The following follow-up parameters will be used: visual analogue pain scale, manual muscle testing, goniometry, centimeter, and preliminary contraction success rate. Their follow-up will be threefold - at the beginning, after 1, and after 6 months. For statistical processing, multiple analysis of variance (MANOVA), with post hoc Bonferroni multiple tests, and Pearson correlation analysis, with post hoc regression analysis, will be used. CONCLUSION: The positive results will allow the preliminary muscle contraction to be used as a universal tool in the rehabilitation, prevention, and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty (international contribution). This maneuver is very short (seconds), easy (everybody can perform it), does not require the allocation of time, space, and resources (including financial ones), and is instantly incorporated into everyday life.

Detailed Description

RESEARCH OBJECTIVE: To investigate the effect of muscle preliminary contraction in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. SCIENTIFIC IDEA: Muscle latency (M1, M2, triggered response, proprioceptive visual/vestibular responses, and M3) leads to chronic damage. During the first 50-200 milliseconds of the movement, there is no internal muscular protective counterforce against external loads on discs, joints, ligaments, insertions, etc. inert structures (including arthroplastic ones), happening thousands of times a day. This leads to repetitive cumulative microtrauma with damage to the "pneumatic hammer" principle, as well as faster wear in arthroplasties. Precontraction of muscles eliminates latency and stabilizes inert (and arthroplastic) structures. WORKING HYPOTHESIS: Muscle preliminary contraction has a significant short-term and long-term effect in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. RESEARCH METHODS: At least 216 patients with degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty, will be studied. They will be randomized into pairwise sub-groups. All will receive standard advice. The maneuver sub¬groups will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. The following follow-up parameters will be used: visual analogue pain scale, manual muscle testing, goniometry, centimeter, and preliminary contraction success rate. Their follow-up will be threefold - at the beginning, after 1, and after 6 months. For statistical processing, multiple analysis of variance (MANOVA), with post hoc Bonferroni multiple tests, and Pearson correlation analysis, with post hoc regression analysis, will be used. CONCLUSION: The positive results will allow the preliminary muscle contraction to be used as a universal tool in the rehabilitation, prevention, and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty (international contribution). This maneuver is very short (seconds), easy (everybody can perform it), does not require the allocation of time, space, and resources (including financial ones), and is instantly incorporated into everyday life.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participants will not know which group they will be in.

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age over 18 years;
  • legal capacity;
  • patients with recurrent degenerative pain (at least two relapses in the last 12 months), in various joints (vertebral, hip, knee, ankle, shoulder, elbow, and knee), in an exacerbation stage (started up to 2 weeks before recruitment), occurring with periodic exacerbations and remissions (relapse duration of more than 24 hours, preceded and separated by remission of at least 1 month);
  • with excitatory (painful) symptoms (but without ablated ones - without paresis, paralysis, and pelvic-reservoir damage);
  • as well as after hip and knee arthroplasty.

Exclusion Criteria

  • age under 18,
  • incapacity;
  • neurological symptoms have disappeared (paresis, paralysis, and pelvic-reservoir disorders),
  • macro-injuries (fractures, dislocations, distortions),
  • structural anomalies, severe osteoporosis, infectious diseases, febrility, malignant diseases, specific inflammatory and autoimmune diseases (such as rheumatoid arthritis, ankylosing spondylarthritis, etc.), mental diseases, increased tendency to bleed (hemophilia, etc.), as well as cardiovascular vascular, respiratory, liver, kidney and metabolic damage with marked failure.

Outcomes

Primary Outcomes

Visual analogue pain scale

Time Frame: At baseline, at 1 month, and at 6 months.

To assess the intensity of pain on a visual analog scale, a 10 centimeters segment is drawn on a piece of paper. The patient notes the intensity of pain on this line between the left end of the line (0=no pain) and the right end (10=maximum pain intensity). The result is registered in centimeters - from 0 to 10 centimeters.

Secondary Outcomes

  • Manual muscle testing(At baseline, at 1 month, and at 6 months.)
  • Range of motion(At baseline, at 1 month, and at 6 months.)
  • Ott's test(At baseline, at 1 month, and at 6 months.)
  • Preliminary muscle contraction success rate(At baseline, at 1 month, and at 6 months.)
  • Centimeter measurements(At baseline, at 1 month, and at 6 months.)
  • Thomayer's test(At baseline, at 1 month, and at 6 months.)
  • Schober's test(At baseline, at 1 month, and at 6 months.)

Investigators

Sponsor
Medical University of Sofia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Assen Aleksiev

Head of Physical Medicine and Rehabilitation Department

Medical University of Sofia

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