Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myofascial Pain Syndrome; Nocturnal Leg Cramps
• Intervention / Treatment: Other: Stretching exercise; Other: Dry needling

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kars, Turkey
    • Kars State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; It describes the exercise protocol that the patients will do.	Other: Stretching exercise; Stretching exercise: Stretching exercises were planned for 30 seconds, ten repetitions for each stretching, 10 minutes in total, four days a week, for two weeks.
Experimental: Exercise plus Dry Needling Group; It describes the exercise protocol to be performed by the patients and the methodology of dry needling to be applied.	Other: Stretching exercise; Stretching exercise: Stretching exercises were planned for 30 seconds, ten repetitions for each stretching, 10 minutes in total, four days a week, for two weeks.; Other: Dry needling; Dry needling: A total of 3 sessions of dry needling, once a week, were applied to the gastrocnemius muscle.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kars State Hospital
• Investigators: Principal Investigator: Fatih Bagcier, M.D., Kars State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): June 25, 2021
• Study Completion (Anticipated): June 25, 2021

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: March 6, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Dry needling; Myofascial trigger point; Calf cramp
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Neuromuscular Manifestations; Parasomnias; Fibromyalgia; Myofascial Pain Syndromes; Spasm; Muscle Cramp; Sleep-Wake Transition Disorders
• Other Study ID Numbers: Biruni University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No