Neuroprolotherapy With Physical Therapy for Treatment of Patellar Chondromalacia

NCT03515720 | Completed

• 1 other identifier: Neuroproloterapia_2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patellar chondromalacia is the degeneration of articular cartilage located on the posterior face of the patella and may suggest the onset of an osteoarthrosis. It predominates in sedentary people who overload the joint, as well as people with insufficiency in the extensor muscles of the knee. It is often seen between 30 and 40 years. Conservative management is the main treatment option and surgical intervention is considered as a last option in a small number of patients. A new treatment option is neuroprolotherapy where the approach is directed at the subcutaneous nerves as the source of pathology, which can lead to neurogenic inflammation and pain.

Conditions

Chondromalacia Patellae

Outcome Measures

Primary Outcomes (1)

• WOMAC Osteoarthritis Index

  The WOMAC Osteoarthritis Index is a specific instrument for osteoarthrosis. It was developed to have a standard and internationally valid measuring instrument to evaluate the results in clinical trials of knee and hip osteoarthritis treatments preferably. It selects three important concepts for the patient and independent of the observer: pain, rigidity and functional capacity. The WOMAC Osteoarthritis Index is obtained from a questionnaire that uses a visual analogical scale for the evaluation of pain (6 questions), rigidity (2 questions) and physical function (17 questions). The best score for each item is 0, using an analog visual scale of 10 centimeters.

  6 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Painful points will be located in the path of the sensory nerves of the knee in which asepsis and antisepsis will be performed, and then 0.5-1 ml of 5% dextrose solution will be applied subcutaneously at a 45º angle along the way. of the nerve with a 27 gauge needle of ½ inch. The number of injections will vary according to the symptoms to be treated. The application will be made once a week for 6 weeks. After the first application of neuroprolotherapy, the patient will be trained to perform a rehabilitation therapy program based on thermotherapy, kinesitherapy and knee strengthening exercises. At the end of the 6 sessions, a new assessment will be made with the WOMAC, EVA and measurement of movement arcs to assess the evolution after treatment.

Procedure: Prolotherapy

Control group

NO INTERVENTION

Physical therapy consisting of 10 sessions based on thermotherapy, kinesitherapy and muscle strengthening exercises to the knee. Subsequently, the patient will perform this therapy home until completing 6 weeks. At the end a new assessment will be made with measurement of movement arcs, WOMAC scale and EVA to assess the evolution after treatment.

Interventions

Prolotherapy PROCEDURE

It consists of injecting 5% dextrose in sterile aqueous solution without the use of lidocaine in a subcutaneous nerve to inhibit neurogenic inflammation and the release of substance P and CGRP, decreasing neurogenic inflammation.

Also known as: Neural prolotherapy

Study group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated in the rehabilitation medicine service of the Specialties Hospital National Medical Center of the West.
• Men and women with clinical and radiographic diagnosis of chondromalacia patellae with or without gonarthrosis.
• Age over 25 years
• Patients expressed their signed consent to participate in the study....

You may not qualify if:

• Patients who have been infiltrated with corticosteroids in the knee during the last year.
• Septic arthritis.
• Systemic infection or cutaneous infection at the site of infiltration.
• Systemic inflammatory disease.
• Joint instability (ligament injuries).
• Meniscopathies
• Intra-articular fracture
• Coagulation disorder or treatment with anticoagulants.
• Diabetes mellitus poorly controlled (\> 130mg / dL).
• Badly controlled systemic arterial hypertension (\> 140 / 90mmHg).
• Hemarthrosis
• Pregnancy.
• Patients with cognitive disorders that prevent the follow-up of indications or carry out the program.
• Patients who do not accept to sign informed consent.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Centro Médico Nacional de Occidente

Guadalajara, Jalisco, 44329, Mexico

Location

Related Publications (14)

• Kim YM, Joo YB. Patellofemoral osteoarthritis. Knee Surg Relat Res. 2012 Dec;24(4):193-200. doi: 10.5792/ksrr.2012.24.4.193. Epub 2012 Nov 29.

  PMID: 23269956 BACKGROUND

• Weglein A. Neural prolotherapy Wonder Why? Journal of Prolotherapy. May 2011; 3(2): 639-643.

  BACKGROUND

• Hauser R, Maddela H, Alderman D, Baehnisch G, Banner R, Blakemore P et al. Journal of Prolotherapy International Medical Editorial Board Consensus Statement on the Use of Prolotherapy for Musculoskeletal Pain. Dec 2011;3(4):744.

  BACKGROUND

• Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med. 2000 Mar;6(2):68-74, 77-80.

  PMID: 10710805 BACKGROUND

• Hauser RA, Sprague IS. Outcomes of prolotherapy in chondromalacia patella patients: improvements in pain level and function. Clin Med Insights Arthritis Musculoskelet Disord. 2014 Feb 17;7:13-20. doi: 10.4137/CMAMD.S13098. eCollection 2014.

  PMID: 24596471 BACKGROUND

• Haspl M, Dubravcic-Simunjak S, Bojanic I, Pecina M. [Anterior knee pain associated with sports and work]. Arh Hig Rada Toksikol. 2001 Dec;52(4):441-9. Croatian.

  PMID: 11831127 BACKGROUND

• Rezasoltani Z, Taheri M, Mofrad MK, Mohajerani SA. Periarticular dextrose prolotherapy instead of intra-articular injection for pain and functional improvement in knee osteoarthritis. J Pain Res. 2017 May 17;10:1179-1187. doi: 10.2147/JPR.S127633. eCollection 2017.

  PMID: 28553139 BACKGROUND

• Maniquis-Smigel L, Dean Reeves K, Jeffrey Rosen H, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial. Anesth Pain Med. 2016 Dec 6;7(1):e42550. doi: 10.5812/aapm.42550. eCollection 2017 Feb.

  PMID: 28920043 RESULT

• Yelland MJ, Sweeting KR, Lyftogt JA, Ng SK, Scuffham PA, Evans KA. Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial. Br J Sports Med. 2011 Apr;45(5):421-8. doi: 10.1136/bjsm.2009.057968. Epub 2009 Jun 22.

  PMID: 19549615 RESULT

• Jara-Oseguera A, Simon SA, Rosenbaum T. TRPV1: on the road to pain relief. Curr Mol Pharmacol. 2008 Nov;1(3):255-69. doi: 10.2174/1874467210801030255.

  PMID: 20021438 RESULT

• Fulkerson JP, Arendt EA. Anterior knee pain in females. Clin Orthop Relat Res. 2000 Mar;(372):69-73. doi: 10.1097/00003086-200003000-00009.

  PMID: 10738416 RESULT

• Friedman AH. An eclectic review of the history of peripheral nerve surgery. Neurosurgery. 2009 Oct;65(4 Suppl):A3-8. doi: 10.1227/01.NEU.0000346252.53722.D3.

  PMID: 19927076 RESULT

• Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.

  PMID: 22515800 RESULT

• Garcia-Triana SA, Toro-Sashida MF, Larios-Gonzalez XV, Fuentes-Orozco C, Mares-Pais R, Barbosa-Camacho FJ, Guzman-Ramirez BG, Pintor-Belmontes KJ, Rodriguez-Navarro D, Brancaccio-Perez IV, Esparza-Estrada I, Bernal-Hernandez A, Gonzalez-Ojeda A. The Benefit of Perineural Injection Treatment with Dextrose for Treatment of Chondromalacia Patella in Participants Receiving Home Physical Therapy: A Pilot Randomized Clinical Trial. J Altern Complement Med. 2021 Jan;27(1):38-44. doi: 10.1089/acm.2020.0287. Epub 2020 Nov 20.

  PMID: 33217236 DERIVED

MeSH Terms

Conditions

Chondromalacia Patellae

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Cleotilde Fuentes Orozco, PhD, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Roberto Mares País, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Sandra Angélica García Triana, MD

  Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• María Fernanda Toro Sashida, MD

  Unit of Physical Medicine and Rehabilitation, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Francisco José Barbosa Camacho, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time surgical researcher

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 3, 2018
• Study Start: November 1, 2018
• Primary Completion: September 20, 2019
• Study Completion: March 1, 2020
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)