A clinical trial to determine the effect of Reflexology therapy in addition to the pharmacological drugs for managing patients suffering from Diabetic Neuropathy

Phase 2

Completed

Conditions: Health Condition 1: null- Diabetic Neuropathy

Registration Number: CTRI/2010/091/001091

Lead Sponsor: Indian Council of Medical Research ICMR New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 71

Inclusion Criteria

1. Age group: any age

2. Both of sex

3. Patients who were residents of Delhi or have arrangement for stay over Delhi for a minimum duration 1 month. And during the follow-up period, the proper correspondence should be available to the laboratory for getting the information about their health status.

This is required for monitoring their health in response to reflexology.

4. Patients who have signed in informed consent proforma

5. Patients with Blood sugar level: greater than or equal to 120mg/decilitre(Fasting) and greater than or equal to 200mg/deciliter (post prandial) for more than 1 occasion

6. Patients with documented peripheral diabetic neuropathy.

Exclusion Criteria

1. Patients non-resident of Delhi or not having any
arrangement to stay in Delhi during the training period
which was 2½ months -3 months
2. Patients with end organ damage (viz., gangrene, toes
or foot amputation) due to diabetes/any cause
3. Patients not willing to sign informed consent from
4. Patients suffering from over-neuropathy
5. Patients with other chronic disorders like malignancy,
T.B., asthma or any communicable disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europathy pain score measured by Visual Analogue Scale (VAS) in the range of 0-10, where 0 indicates no pain while 10 indicates excruciating painTimepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life in neuropathy as measured by neuroQOL, responses on the reflex areas, objective and subjective parameters.<br>Abnormal features recorded on the reflex areas:<br>(i)Tenderness<br>(ii)Hollowness formation<br>(iii)Abnormal pigmentation<br>(iv)Swelling <br>(v)Corn formation <br>Objective parameters:<br>(i)Blood sugar level F & PP<br>(ii)Glycosylated HbA1c<br>(iii)Blood pressure<br>(iv)Frequency of urination<br>(v)Nerve conduction velocity<br>(vi)Vibration sensitivity<br>(vii)Thermal sensitivity<br>Subjective parameters (standard questionnaire):<br>(i)Numbness in the legs/ feet<br>(ii)Tingling sensation<br>(iii)Difficulty in walking<br>(iv)Difficulty in standing<br>(v)Burning sensation<br>Timepoint: 6 months for all the secondary outcome measures