Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps

Not Applicable

• Conditions: Myofascial Pain Syndrome; Nocturnal Leg Cramps
• Interventions: Other: Stretching exercise; Other: Dry needling

• Registration Number: NCT04789811
• Lead Sponsor: Kars State Hospital

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-02-27
• Study First Submitted QC: 2021-03-06
• Study First Posted: 2021-03-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-10
• Primary Completion: 2021-06-25
• Study Completion: 2021-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise plus Dry Needling Group	Stretching exercise	It describes the exercise protocol to be performed by the patients and the methodology of dry needling to be applied.
Exercise plus Dry Needling Group	Dry needling	It describes the exercise protocol to be performed by the patients and the methodology of dry needling to be applied.
Exercise Group	Stretching exercise	It describes the exercise protocol that the patients will do.

Primary Outcome Measures

Name	Time	Method
Change in cramp intensity levels with visual analog scale	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 Number of Cramps	3 months	How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome
Change in algometric sensitivity measurement	3 months	Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.
Change in calf cramp duration	3 months	How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome
Change in sleep quality	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.

Trial Locations

Locations (1)

Kars State Hospital; 🇹🇷 Kars, Turkey