Prolotherapy injections for chronic low-back pain

 

Abstract

Background

Prolotherapy involves repeated injections of irritant solutions to strengthen lumbosacral ligaments and reduce some types of chronic low-back pain; spinal manipulation and exercises are often used to enhance its effectiveness.

Objectives

To determine the efficacy of prolotherapy in adults with chronic low-back pain.

Search methods

We searched CENTRAL 2006, Issue 3 and MEDLINE, EMBASE, CINAHL, and AMED from their respective beginnings to October 2006, with no restrictions on language, and consulted content experts. Literature search was updated on July 29th, 2009. No new RCTs were identified.

Selection criteria

We included randomised (RCT) and quasi-randomised controlled trials (QRCT) that compared prolotherapy injections to control injections, alone or in combination with other treatments, which measured pain or disability before and after the intervention.

Data collection and analysis

Two review authors independently selected the trials and assessed methodological quality. Intervention protocols varied from study to study, making meta-analysis impossible.

Main results

We identified five high quality studies with a total of 366 participants. All measured pain or disability levels at six months, and four measured the proportion of participants reporting a greater than 50% reduction in pain or disability scores.

Three randomised controlled trials (206 participants) found that prolotherapy injections alone are no more effective than control injection for chronic low-back pain and disability. At six months, there was no difference between groups in mean pain or disability scores (2 RCTs; 184 participants) and no difference in proportions who reported over 50% improvement in pain or disability (3 RCTs; 206 participants). These trials could not be pooled due to clinical heterogeneity.

Two RCTs (160 participants) found that prolotherapy injections, given with spinal manipulation, exercise, and other therapies, are more effective than control injections for chronic low-back pain and disability. At six months, one study reported a significant difference between groups in mean pain and disability scores, whereas the other study did not. Both studies reported a significant difference in the proportion of individuals who reported over 50% reduction in disability or pain. Co-interventions confounded interpretation of results and clinical heterogeneity in the trials prevented pooling.

Authors' conclusions

There is conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-back pain. When used alone, prolotherapy is not an effective treatment for chronic low-back pain. When combined with spinal manipulation, exercise, and other co-interventions, prolotherapy may improve chronic low-back pain and disability. Conclusions are confounded by clinical heterogeneity amongst studies and by the presence of co-interventions.

 

Plain language summary

Prolotherapy injections for chronic low-back pain

Chronic low-back pain is a very common problem for which there is currently no universally effective treatment. Patients with chronic low-back pain have many treatment options and it is important for them to understand the evidence behind each treatment option they may be considering. Prolotherapy injections have been used to treat chronic low-back pain for over 50 years but their use remains controversial. They involve repeatedly injecting ligaments with compounds such as dextrose (sugar) and lidocaine (anaesthetic) to help restart the body's natural healing process by causing controlled acute inflammation (swelling) in the areas injected. Proponents believe this leads to stronger ligaments that can better support the low-back. Prolotherapy injections are often combined with other treatments such as spinal manipulation, exercises, and corticosteroid injections into tender muscles to maximize its effect.

This review included five studies that examined the effects of prolotherapy injections on 366 patients with low-back pain that had lasted for longer than three months. Because these studies used different types of prolotherapy injections and different treatment protocols, their results could not be combined. The five studies we examined were therefore divided according to whether they used prolotherapy injections alone or combined prolotherapy injections with spinal manipulation, exercise, and other treatments. Of the five studies we reviewed, three found that prolotherapy injections alone were not an effective treatment for chronic low-back pain and two found that a combination of prolotherapy injections, spinal manipulation, exercises, and other treatments can help chronic low-back pain and disability. Minor side effects such as increased back pain and stiffness were common but short-lived. Based on these five studies, the role of prolotherapy injections for chronic low-back pain is still not clear.

 

摘要

背景

Prolotherapy 注射治療慢性下背痛

Prolotherapy 乃使用刺激性溶液反覆注射來強化腰薦椎韌帶和減輕某些種類的下背痛；脊椎調理與運動則常使用來加強它的治療效果。

目標

為評估 prolotherapy對成人慢性下背痛 的治療效果。

搜尋策略

搜尋CENTRAL 2006, Issue 3 和 MEDLINE、 EMBASE、CINAHL、與 AMED，從最初至2006年10月、不限語言的論文、並參考有關專家們的意見。

選擇標準

收集隨機與類隨機對照試驗，比較prolotherapy 注射與控制組注射(包含單獨注射或合併其它治療)，並評估治療前與治療後疼痛與失能的程度。

資料收集與分析

兩個回顧論文的作者，獨立選擇試驗並評估其使用方法的品質。由於各個不同試驗研究，採取不同的處置方法，因而無法做進一步的Meta分析。

主要結論

我們選定了5篇高品質的研究，共有366名測試者。所有的研究皆測量在治療後6個月的疼痛或失能的程度。4個研究報告了測量大於50 ％減少疼痛或失能評分的受試者比例。3個隨機對照試驗(206人)發現， 單獨prolotherapy注射本身沒有比控制組注射對慢性下背痛和失能為有效。在6個月時，各組間的平均疼痛或失能分數沒有任何差異(2個隨機對照試驗 184位受試者)。報告超過50 ％的改善疼痛或失能的比例各組間亦無差異(3個隨機對照試驗 206位受試者)。這些試驗因為臨床條件不同所以不能相加。根據2個臨床隨機對照試驗(160位受試者)發現， prolotherapy注射合併脊柱調理，運動，和其他治療，則會比控制組注射對慢性下背痛和失能更有效。在6個月，一個研究報告了各組間在平均痛苦和失能分數有顯著性差異，而另一個研究卻沒有差異。但這兩個研究報告，超過50 ％減少疼痛或失能的受試者比例在各組間則報告有顯著性差異。由於各篇研究對於研究結果的解釋不同及其臨床的異質性，而無法合併各篇研究的病例，來做進一步的分析研究。

作者結論

使用prolotherapy注射，來治療慢性下背痛的效力，在研究證據上是有其矛盾的。當單獨使用 prolotherapy注射，來治療慢性下背痛時，是不具效用的。當同時結合脊柱調理、運動、和其他處置措施時，prolotherapy注射則可改善慢性下背痛和失能。研究的結論會因為各臨床研究的異質性和其他處置措施的同時存在，而造成困惑。

翻譯人

本摘要由林口長庚醫院牛自健翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Prolotherapy注射治療慢性下背痛 慢性下腰痛是一種非常常見的問題，在這方面目前還沒有普遍有效的治療方法。對於有慢性下背痛的病人，有許多可選擇的治療方法，但重要的是，病患要了解他們所考慮選擇的治療方法之治療證據。 。 Prolotherapy注射已用於治療慢性下背痛50多年，但其使用效果仍然有爭議。它們涉及多次注射化合物進到韌帶裡，如注射葡萄糖(糖)和利多卡因(麻醉劑)，以造成注射區域形成可控制之急性發炎(腫脹)狀態，從而幫助重新啟動人體的自然癒合過程。倡議者認為這樣造成了更強有力的韌帶，可以更好地支持下背部。 Prolotherapy注射往往結合其他療法如脊椎調理，運動，和皮質類固醇注射進入壓痛的肌肉而產生最大地治療作用。 這項審查包括5個研究報告，審查了影響prolotherapy注射對366例持續時間超過三個月的下背痛病人。由於這些研究使用不同類型的prolotherapy注射和不同的治療方案，其結果不能結合。我們的五項研究審查，因此劃分是否單獨使用prolotherapy注射或聯合注射，脊椎調理，運動，和其他治療方法。我們審查的五個研究，其中三個研究發現，僅用prolotherapy注射，並無法有效的治療慢性下背痛。另有兩個研究發現，結合prolotherapy注射、脊椎調理、運動、和其他治療方法，則可以幫助慢性下背痛和失能的改善。輕微的副作用，包括短暫地增加背部疼痛和僵硬等。基於上述五個研究，prolotherapy注射，在治療慢性下背痛的角色，目前仍不清楚。