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Manual Therapy and Exercise in Low Back Pain

Effects of a Procedure Programme in Patients With Non-specific Low Back Pain. Comparative Intervention Based on Therapeutic Exercise, Therapeutic Exercise With Kinesio Tape and Manual Therapy Prior to the Therapeutic Exercise

Non-specific low back pain is one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity is electromyography.

Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.

The main objective that is aimed by this thesis, is the evaluation of muscular activation in the reduction of non-specific low back pain through a 12 weeks procedure programme, which includes therapeutic exercise combined with other treatment techniques, and assessing the psycho-social characteristics of pain.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 20 and 80.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: the experimental group or EXP Group (all participants subject to therapeutic exercise), the experimental group, which will also be subject to manual therapy (MT Group) and finally, the experimental group, which will also be subject to kinesio tape work (KT Group).

研究の種類

介入

入学 (実際)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年~50年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Patients diagnosed with low back pain.
  • Patients who are in Stage 1 of the Oswestry scale.
  • Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids
  • Be able to understand the exercises and spanish language.

Exclusion Criteria:

  • Having any back surgery.
  • Be taking any medication at the time of the study.
  • Have a pathology in which exercise is contraindicated (spondylolisthesis, spondylolysis, spondyloarthrosis).
  • Be in a state of gestation or if there is the possibility of being.
  • Present or have presented some oncological process.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Experimental Group (EXP group)
The experimental group (EXP Group) is going to follow a programme of stabilisation through specific therapeutic exercises of the lumbopelvic centre. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each sesión will have a duration of 60 minutes, the first 5 minutes for a warm-up and the last 10 for a cool-down phase of active stretching. All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercices will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercies of 2-3 minutes.
All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
他の名前:
  • 筋骨格操作
  • キネシオテーピング
アクティブコンパレータ:Experimental Group and Manual Therapy (MT Group)
Additionally to the core exercises previously exposed in Group EXP, Group MT will lay on the stretcher first, where the physiotherapist will work on a manual therapy thrust. The patient will receive an impulse technique in lateral decubitus position, with high velocity and low range on both sides.
All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
他の名前:
  • 筋骨格操作
  • キネシオテーピング
アクティブコンパレータ:Experimental Group and Kinesio Tape (KT Group)
The experimental group plus kinesio tape (KT Group) will go previously through physiotherapy, where a kinesio tape band will be applied (kinesio tape "Nondolens" 5cm x 5cm black color), in Y technique, by applying the KT base in neutral position of the lumbar spine without any tension on the tape.
All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
他の名前:
  • 筋骨格操作
  • キネシオテーピング

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Oswestry
時間枠:(12 weeks)
The Oswestry (ODI) test will be made to all participants at three months. The results of this scale will provide the necessary information to know the degree of symptomatology of the patient and will therefore help in the planification and procedure to the patient. That is why, it has been established that all participants in Stage 1 of the test are subsidiaries to make all the treatment modes of the study (manual therapy and exercise). This way, we are able to rise the homogeneity that imposes a diagnostic label such as the chronic low back pain.
(12 weeks)

二次結果の測定

結果測定
メジャーの説明
時間枠
Kinesiophobia (TKS)
時間枠:(12 weeks)

The mostly used questionnaire to evaluate kinesiophobia is the TKS (Tampa Kinesiophobia Scale) questionnaire, which we will use to measure which is the fear to movement of patients of low back pain. This scale includes work related lesions, lesions due to repetitive effort, relapses and the avoidance-fear. The questionnaire is composed of 17 items in which there is a differentiation between the negative an positive elements.

This questionnaire will be filled in based on a Likert scale which ranges between 0 and 5, being 0 never and 5 always. The total punctuation ranges between 17 and 68, the higher the rate, the higher the degree of kinesiophobia.

(12 weeks)
Catastrophism (PCS)
時間枠:(12 weeks)
To quantify the degree of catastrophism in the present study, the validated spanish version will be used as the pain catastrophism scale (PCS). The PCS is a 13-item self-report scale of 13 items, that presents same factor structure composed of the factors of rumination, despair and magnification. For each of these factors, it is given a value of 0 (without agreement) to 4 (always), so that at the end the examiner obtains a score between 0 and 52. Low scores indicate a low level of catastrophism and high values show high levels of catastrophism.
(12 weeks)
Self-efficacy: questionnaire
時間枠:(12 weeks)
To assess self-efficacy, it will be used the Chronic Pain Self-Efficacy Questionnaire, which assesses a person's belief in their ability to perform a specific behavior. It consists of 19 items, a Likert-type scale and a response range of 0 to 10, where 0 is equivalent to feeling totally incapable, 5 moderately incapable and 10 fully capable. The result determines that the higher the score, the greater the degree of self-efficacy.
(12 weeks)
Visual analog scale (VAS)
時間枠:(12 weeks)
The VAS from 0 to 100, the scale considered to be the most representative, with the VAS being the best option due to its easy understanding and handling. This scale constitutes an effective tool to subjectively quantify this range, more discriminating than the scale that establishes its values from 0 to 10. This way, 0 will be considered as non-existent pain reflected by the individual and 10 as the worst pain imaginable by the patient.
(12 weeks)
Pressure algometry
時間枠:(12 weeks)
Pressure algometry is considered a useful method to calculate the degree of sensitization of deep tissues. It will be carried out using an algometer, which in this study will consist of a manometer attached to a cylindrical rubber tip. The manometer measures the pressure applied through the rubber and the patient should signal when this pressure starts being painful. This way, it will be established the pressure pain threshold (PPT). Algometry is a widely studied and validated technique to quantify sensitivity in the diagnosis of symptomatic points and myofascial trigger points. The reliability of pressure algometry is relatively high, presenting coefficients of 0.9 and 0.95.
(12 weeks)
Electromyography
時間枠:(12 weeks)

to obtain an objective measure of the muscle activation, surface electromyography will be used to evaluate the main core muscles - basically the transverse abdomen.

The electromyograph to be used will be the FREEEMG model of the brand BTS Bioengineering. It is a wireless electromyograph with probes attached to the prefilled electrodes, which collect the information. No additional hardware is required, as the same software processes the information taken. The data resolution is 16 bit and the acquisition frequency of 1 kHz.

(12 weeks)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディディレクター:Juan Vicente Mampel, Phd、Fundación Universidad Católica de Valencia San Vicente Mártir

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年3月1日

一次修了 (実際)

2021年12月23日

研究の完了 (実際)

2021年12月23日

試験登録日

最初に提出

2020年10月19日

QC基準を満たした最初の提出物

2021年6月9日

最初の投稿 (実際)

2021年6月14日

学習記録の更新

投稿された最後の更新 (実際)

2022年1月28日

QC基準を満たした最後の更新が送信されました

2022年1月27日

最終確認日

2022年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • UCV/2019-2020/138

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いいえ

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