Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947451
• Other study ID #: TCC_Isabel
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2020
• Source: Universidade Federal do Ceara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with knee Osteoarthritis have high prevalence of pain , requiring ever more precise interventions in their management. This study aims to investigate the immediate effects of manual therapy and TENS on pain in patients with knee Osteoarthritis. Knowledge of best interventions favors reducing spending on health and safety for the patient.

Description:

This study aims to compare the efficacy of manual therapy and TENS for immediate control of pain in patients with knee osteoarthritis. They will be included 62 patients with clinical and radiological diagnosis of knee osteoarthritis, presenting pain of at least 3 in VAS, which are recruited from rheumatology and geriatrics clinics in Fortaleza / CE through a prior screening.

Will be three assessments, prior to the intervention, immediately after it and after 72 hours. The data collected shall appear in individual printed records. Participants will be divided into two therapy groups, of which one will be applied manual therapy and other TENS. There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.

In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee.

In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application. The intensity will be defined by the patient, should the stimulus be considered intense, but pleasant to it.

The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Knee osteoarthritis diagnosed by clinical criteria established by the American College of Rheumatology and radiological criteria of Kelgren-Lawrence

• Age over 50 years

• Pain intensity above 2 on the VAS

Exclusion Criteria:

• Other systemic inflammatory disease

• Changes in sensitivity

• Use of anti-inflammatory steroids, tranquillizers and/or antidepressants in the last month

• Analgesic in last 24 hours

• Use of cardiac pacemaker

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Manual Therapy
In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee. Stretching, myofascial release and mobilizations will be held for 30 seconds, with three repetitions of each. The intervention will be applied only once.
• TENS
In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50µs for 40 minutes in a single application. The intensity will be defined by the patient, should the stimulus be considered intense, but pleasant to it.

Locations

Country	Name	City	State
Brazil	Federal University of Ceara	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Gabriel Peixoto Leão Almeida

Country where clinical trial is conducted

Brazil, 

References & Publications (25)

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McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. — View Citation

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Nnoaham KE, Kumbang J. WITHDRAWN: Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2014 Jul 10;(7):CD003222. doi: 10.1002/14651858.CD003222.pub3. Review. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity in Visual Analogic Scale	It consists of 11 points, ranging from 0 ( no pain) to 10 ( maximum possible pain ), the volunteer instructed to quantify their knee pain present at the time of evaluation.	Immediately
Primary	Pressure Pain Threshold in Algometer	They will be scored 7 points, the first being located at the apex of the patella, the second three cm medial to the apex of the patella, the third two centimeters higher than the second, the fourth two centimeters lower than the second, the fifth three centimeters lateral to the apex of the patella, the sixth two centimeters above the fifth and seventh two centimeters below the fifth.; Participants will be instructed to report to the appraiser whenever the feeling in the stimulus site becomes clearly painful. There will be two measurements at each point, each starting from point 1 to 7. It shall be considered the average of each isolated point and the average of the averages of the points how test result.	Immediately
Secondary	Global Rating of Change Scale	Used to evaluate the self- perception of the volunteer about the overall state of the affected knee. It is formed by 11 points, ranging from -5 (much worse), 0 (unchanged) to +5 (completely better), the participant instructed to quantify their perception with the question: "Compared to their condition before the treatment, how would you describe your knee right now?"	Immediately and 72 hours after intervention
Secondary	Pain intensity in Visual Analogic Scale 72 hours after intervention	It consists of 11 points, ranging from 0 ( no pain) to 10 ( maximum possible pain ), the volunteer instructed to quantify their knee pain present at the time of evaluation.	72 hours after intervention
Secondary	Pressure Pain Threshold in Algometer 72 hours after intervention	They will be scored 7 points, the first being located at the apex of the patella, the second three cm medial to the apex of the patella, the third two centimeters higher than the second, the fourth two centimeters lower than the second, the fifth three centimeters lateral to the apex of the patella, the sixth two centimeters above the fifth and seventh two centimeters below the fifth.; Participants will be instructed to report to the appraiser whenever the feeling in the stimulus site becomes clearly painful. There will be two measurements at each point, each starting from point 1 to 7. It shall be considered the average of each isolated point and the average of the averages of the points how test result.	72 hours after intervention