The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia

NCT ID: NCT02865200

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-12-31

Brief Summary

Aim: This study was planned for comparing physical activity levels, nutrition quality and quality of life of the individuals that are diagnosed with and without metabolic syndrome (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).

Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic characteristics of the individuals that participated the study were registered with a survey form. The long form of the International Physical Activity Questionnaire was used for determining physical activity levels of the individuals; whereas total numbers of daily steps were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS) was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for the assessment of health-related qualities of life of individuals and Beck Depression Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis and anthropometric measurements of individuals were also taken.

Conditions

Metabolic Syndrome; Physical Activity; Quality of Life

Study Design

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

Study Groups

Dry Needling Application

Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique. The needles were kept on the body for 20 minutes and at the 10th minute, the needle was rolled and re-stimulation was enabled. The treatment was applied twice a week, which is equal to 6 sessions in total.

Group Type: EXPERIMENTAL

Dry Needling Application

Intervention Type: OTHER

Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique.

Classic Physiotherapy Program

Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again. The period of treatment was 6 sessions in total with 25 minutes of each.

Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.

Group Type: EXPERIMENTAL

Classic Physiotherapy Program

Intervention Type: OTHER

Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again.

Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.

Interventions

Dry Needling Application

Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique.

Intervention Type: OTHER

Classic Physiotherapy Program

Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again.

Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients among the ages of 35-70,
• Suffering from LBP for at least 3 months,
• Diagnosed with LDH having at least 1 active trigger point that can be cooperated .

Exclusion Criteria

• Those with LDH that show neurological symptom,
• Having any orthopaedic problem at lower extremity and lower back region,
• Having sacroiliac joint problem, diagnosed with lumbar spondylolisthesis,
• Having any neurologic, rheumatic, oncologic problem,
• Who received any physiotherapy program at least 6 months before, patients having any corticosteroid treatment or oral medication
• Those having needle phobia were not included in the trial.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Ender Angın

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EasternMU

Identifier Type: -

Identifier Source: org_study_id