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Clinical Trials/NCT04789811
NCT04789811
Unknown
Not Applicable

The Effectiveness of Exercise and Dry Needling Treatment Combination in Patients With Nocturnal Calf Cramps

Kars State Hospital1 site in 1 country50 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nocturnal Leg Cramps
Sponsor
Kars State Hospital
Enrollment
50
Locations
1
Primary Endpoint
Change in cramp intensity levels with visual analog scale
Last Updated
4 years ago

Overview

Brief Summary

The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp.

Detailed Description

Nocturnal leg cramps are sudden, involuntary, painful contractions of the lower extremity in the nighttime, most often in the calf muscles, that gradually lessens. Its etiology is not clear. It can be seen in electrolyte disturbances, drug side effects, neuromuscular diseases, diabetes mellitus, peripheral vascular pathologies. It has been mentioned in the literature that myofascial trigger points in the gastrocnemius muscle may be associated with nocturnal calf cramps. Our aim in this study is to evaluate the effectiveness of the combination of stretching exercises and dry needling therapy on cramp duration, cramp intensity, cramp frequency, sleep quality, and algometer measurement in patients with nocturnal calf cramps and whose had myofascial trigger point in the gastrocnemius muscle.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
June 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel

Investigators

Sponsor
Kars State Hospital
Responsible Party
Principal Investigator
Principal Investigator

Fatih Bagcier

Principal Investigator

Kars State Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with only nocturnal calf cramp
  • Patients with a trigger point in the unilateral gastrocnemius muscle
  • Being between the ages of 18-50

Exclusion Criteria

  • Patients using diuretics or hypertension medications that may trigger cramping
  • Those with a chronic disease history
  • Those diagnosed with spinal stenosis
  • Electrolyte disturbance in laboratory tests

Outcomes

Primary Outcomes

Change in cramp intensity levels with visual analog scale

Time Frame: 3 months

How intense the cramp felt by the patient was recorded with a visual analog scale. The score is between 0 to 10, and higher values represent a worse outcome.

Change in algometric sensitivity measurement

Time Frame: 3 months

Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.

Change in Number of Cramps

Time Frame: 3 months

How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome

Change in calf cramp duration

Time Frame: 3 months

How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome

Change in sleep quality

Time Frame: 3 months

The sleep quality of the patients was evaluated with the Pittsburgh Sleep Quality index. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Study Sites (1)

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