Clinical and Ultrasonographic Comparison of the Effect of Hot and Cold Therapy on Spasticity

NCT ID: NCT04775511

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2023-04-01

Brief Summary

Spasticity is a positive sign of upper motor neuron syndrome. The frequency of spasticity development in patients with stroke is 38%. Spasticity is one of the important factors that negatively affect the rehabilitation potential and functional recovery of the patient. In the treatment of spasticity, oral antispasticide drugs, phenol, ethyl alcohol, botulinum toxin, and chemical nerve and motor point blocks, physical therapy, and rehabilitation, surgical methods are used. In the physical therapy rehabilitation program of spasticity, stretching and strengthening exercises, cold application, warm application, ultrasound therapy, electrical stimulation, biofeedback, extracorporeal shock therapy are used. Stretching exercises are the cornerstone of spasticity treatment. In many clinical and experimental studies, a decrease in spasticity has been noted after stretching exercises. It has been stated that the application of cold or hot applications before stretching may increase the effectiveness of spasticity treatment. The study comparing the effectiveness of hot and cold treatment applied before stretching exercises clinically and ultrasonographically has not been found in the literature. The purpose of this study is the evaluation of clinical and ultrasonographic comparison of the effect of hot and cold treatment on spasticity before stretching exercises in patients with stroke. This study is unique because it is the first study that evaluates the effect of hot and cold applications on spasticity before the stretching.

Detailed Description

The study is a randomized and controlled study. 30 patients will be included to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of spasticity after stroke, aged between 18-75 years. These patients will be divided in three groups randomly (group1 n:10, group 2 n:10, group 3 n:10).

First group: 20 minutes of hot pack application to the medial gastrocnemius muscle. Then the patient will do stretching exercises to the gastrocnemius muscle, which will be done for 20 minutes. In hot pack for hot application; While the patient is lying in a prone position, a warm package, a towel between the skin and the skin will be applied on the gastrocnemius muscle and applied for 20 minutes.

Second group: 20 minutes to apply a cold pack to the medial gastrocnemius muscle, followed by stretching the patient for 20 minutes to the gastrocnemius muscle. The cold pack is available for cold application; While the patient is lying in a prone position, a cold pack will be placed on the gastrocnemius muscle, and a towel will be applied for 20 minutes.

Third group: 20 minutes of stretching and stretching exercises will be applied.

In stretching exercises, stretching will be done for 30 seconds. The stretching exercise will be performed by the same physiotherapist with maximal tension to the ankle in the supine position of the patient in the hip and knee extension.

These applications will continue as 5 sessions. Evaluations will be made before treatment, immediately after the first session and at the end of the 5th session. All patients will be evaluated for 3 times, before and after treatment and 5 session after the treatment with ultrasonographic measurements, ankle range of motion and spasticity degree.

Primary aim of this study is to evaluate the effect of hotpack and cold pack applicatios on Madial gastrokinemius ultrasonographic changes. For this purpose, medial muscle fascicule length, pennat angle and achilles tendon length with ultrasonographic measurement.

Secondary aim is evaluating the effect of hot and cold pack on spastisity and ankle range of motion. Spastisity will be measured by Aschwort scale and range of motion will be measured by goniomertry.

Conditions

Spastic Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Heat Therapy with heating pads

20 minutes of heating pads will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and heating pads, and heating pads will be placed on the gastrocnemius muscle.

Group Type: EXPERIMENTAL

Heat Therapy with heating pads

Intervention Type: OTHER

20 minutes of heating pads will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and heating pads, and heating pads will be placed on the gastrocnemius muscle.

Cold Therapy with ice packs

20 minutes of ice packs will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and ice packs, and ice packs will be placed on the gastrocnemius muscle.

Group Type: EXPERIMENTAL

Cold Therapy with ice packs

Intervention Type: OTHER

20 minutes of ice packs will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and ice packs, and ice packs will be placed on the gastrocnemius muscle.

Stretching Exercises

20 minutes of stretching exercises will be applied. In stretching exercises, stretching will be done for 30 seconds. The stretching exercises, which contain the maximal tension to the ankle, will be performed by the same physiotherapist while the patient is in the supine position, hip and knee extension.

Group Type: OTHER

Stretching Exercises

Intervention Type: OTHER

20 minutes of stretching exercises will be applied. In stretching exercises, stretching will be done for 30 seconds. The stretching exercises, which contain the maximal tension to the ankle, will be performed by the same physiotherapist while the patient is in the supine position, hip and knee extension.

Interventions

Heat Therapy with heating pads

20 minutes of heating pads will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and heating pads, and heating pads will be placed on the gastrocnemius muscle.

Intervention Type: OTHER

Cold Therapy with ice packs

20 minutes of ice packs will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and ice packs, and ice packs will be placed on the gastrocnemius muscle.

Intervention Type: OTHER

Stretching Exercises

20 minutes of stretching exercises will be applied. In stretching exercises, stretching will be done for 30 seconds. The stretching exercises, which contain the maximal tension to the ankle, will be performed by the same physiotherapist while the patient is in the supine position, hip and knee extension.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being first stroke attack
• Grade ≥1 Spasticity in the medial gastrocnemius muscle according to modified ashwort scale
• At least 6 weeks have passed since the stroke

Exclusion Criteria

• Antispasticidal drug use
• Botulinum toxin injection into the gastrocnemius muscle
• Having another nervous system or orthopedic disease that can affect measurements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Banu Dilek

Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Banu Dilek

Role: CONTACT

banu.dilek@deu.edu.tr

+905052248340

Facility Contacts

Banu Dilek

Role: primary

banu.dilek@deu.edu.tr

Other Identifiers

DokuzUS

Identifier Type: -

Identifier Source: org_study_id