Patients and Methods

Framework and Setting. In October 1994, the authors started a Christian charity medical clinic called Beulah Land Natural Medicine Clinic in an impoverished area in southern Illinois. The primary modality of treatment offered was Hemwall-Hackett dextrose Prolotherapy for pain control. Dextrose was selected as the main ingredient in the solution because it is the most common proliferant used in Prolotherapy, is readily available, is inexpensive when compared to other proliferants, and has a high safety profile. The clinic met every three months until it ended in July 2005. All treatments were given free of charge.

FIGURE 1. Typical injection sites for Hemwall-Hackett dextrose Prolotherapy of the TMJ.

Patient Criteria. General inclusion criteria included being at least 18 years old, having TMD for more than six months, and a willingness to undergo at least four Prolotherapy sessions (unless the pain remitted with fewer sessions).

Interventions. Each patient received four to six injections of a 15% dextrose, 0.2% lidocaine solution with a total of two to four cc’s of solution used per temporomandibular joint. Typically, one cc of solution was injected into the joint and the remaining solution was injected onto the TMJ ligament and capsular attachments on the zygomatic arch and mandibular condyle and neck (See Figures 1 and 2). The patients were asked to hold their mouths half open while the injections were given. No other therapies were used. The patients were asked to reduce or stop other pain medications and therapies they were using as much as the pain would allow.

FIGURE 2. Ligamentous structures of the TMJ typically treated with Hemwall-Hackett dextrose Prolotherapy.

Data Collection. Patients who were seen in the clinic in the years from 2001- 2005 and met the inclusion criteria were called by telephone and interviewed by an independent data collector who had no prior knowledge of Prolotherapy and was the sole data collector gathering the patient information during the telephone interviews. The patients were asked a series of detailed questions about their pain and previous treatments before starting Prolotherapy. Their response to Prolotherapy treatments was also documented in detail with an emphasis on the effect the treatments had on their need for subsequent pain treatments, as well as their quality of life. Specifically, patients were asked questions concerning years of pain, pain intensity, overall disability, number of physicians seen, medications taken, stiffness, crunching sensations in the joint, quality of life concerns, and psychological factors. Also noted was whether the post-treatment benefits continued substantially after the sessions concluded.

Statistical Analysis. For the analysis, the results of the patient responses were calculated by another independent data collector who had no prior knowledge of Prolotherapy. Pre-prolotherapy treatment responses were compared with the patients’ responses to the same questions after Prolotherapy treatment.

Patient Characteristics. Complete data was obtained on 14 patients who met the inclusion criteria. Of the 14 study participants, 63% were female and 37% were male. The average age was 50. Patients reported an average of 5.4 years in pain. Fifty-one percent had pain greater than six years. The average patient saw four medical doctors before receiving Prolotherapy. Fifty percent of the patients were told by their physicians that no other treatment options existed for their pain problem and 14% were told that surgery was their only option. Thirty-one percent were taking one pharmaceutical drug, while 39% were taking two or more drugs for pain (See Table 1).

Treatment Outcomes

Patients received an average of 4.6 Prolotherapy treatments. The average time of follow-up from their last Prolotherapy session was eighteen months.

Pain, Crunching Sensation, and Stiffness. patients were asked to rate their pain and stiffness on a scale of 1 to 10, with 1 being no pain/stiffness and 10 being severe, crippling pain/stiffness. The 14 patients had an average starting pain level of 5.9, crunching sensation in the TMJ of 5.5, and stiffness of 5.4. Their average ending pain, crunching, and stiffness levels were 2.5, 2.7, and 2.4 respectively (See Figure 3). Over 71% percent said that they had retained at least 75% of the improvements and 91% noted that they retained at least 50% of their improvements in their pain, crunching, and stiffness levels since the last treatment session. Ninety-three percent of patients reported that pain relief was at least 50% while 57% reported greater than 75% pain relief. Only one person noted that the long term pain relief was only somewhat successful in having only 25-49% of the pain relieved.

Range of Motion. Patients were asked to rate their range of motion on a scale of 1 to 7, with 1 being no motion, 2 through 5 were fractions of normal motion, 6 was normal motion, and 7 was excessive motion. The average starting range of motion was 4.3 and ending range of motion was 5.1. Before Prolotherapy, 29% had very limited motion (49% or less of normal motion). This decreased to only 7% after treatments were concluded.

Pain Medication Utilization. Seventy-one percent discontinued pain medications altogether after Prolotherapy. In all, 90% of patients on medications at the start of Prolotherapy were able to decrease them by 75% or more. None of the patients had to increase pain medication usage after stopping Prolotherapy. Fifty-seven percent of patients needed no additional pain management care after Prolotherapy. After Prolotherapy, 93% of patients were able to decrease additional pain management care by 50% or more.

FIGURE 3. Starting and ending pain, crunching, and stiffness levels before and after receiving Hemwall-Hackett dextrose Prolotherapy in 14 patients with unresolved TMJ pain.

Disability. In regard to quality of life issues prior to receiving treatment, 50% exhibited overall disability of at least 50% in that they could only do about half of the jaw motions without pain. This decreased to 7% after Prolotherapy. In regard to overall TMJ disability, only 14% noted almost no disability (25% or less) prior to Prolotherapy, but this increased to 72% after treatment(See Figure 4).

Depression & Anxiety. Prior to Prolotherapy, 56% of patients reported feelings of depression and 64% reported feelings of anxiety. After treatments, only 28% reported depressed feelings and 36% reported feelings of anxiety (See Figures 5 and 6). Patients reported that on average 86% of the improvements in depression and anxiety have at least somewhat continued. Seventy-eight percent of these patients reported 75% continuing improvement at the time of follow-up.

Sleep. Sixty-four percent of patients reported their pain interrupted their sleep prior to Prolotherapy treatments and 55% of them subsequently showing improvements in their sleeping ability after treatments.

Quality of Life. To a simple yes or no question, “Has Prolotherapy changed your life for the better?” 100% of patients treated answered “yes.” In quantifying the response,

• Eighty-six percent felt their life was at least very much better from Prolotherapy
• Sixty-nine percent stated that the results from Prolotherapy have very much continued to this day (75% or greater).
• One hundred percent felt that they still have some benefits (at least 25%) from the Prolotherapy they received.

Patients who experienced regression of some of their symptoms were asked, “Are there reasons beside the Prolotherapy effect wearing off that are causing some return of your pain/disability?” 79% answered “yes.” The patients noted the reasons for some of their returning pain were the following:

• stopped Prolotherapy treatments too soon, (before pain was completely gone):37%
• re-injury: 14%
• increased life stressors: 21%
• new area of pain: 7%

Of the patients whose pain recurred after Prolotherapy was stopped, 58% were planning on receiving additional Prolotherapy treatments.

Patient Satisfaction. Eighty-six percent of patients knew someone who had benefited from Prolotherapy. In fact, 44% came to receive their first Prolotherapy session at the recommendation of a friend who had already received Prolotherapy. Ninety-three percent of patients treated considered the Prolotherapy treatment to be very successful (greater than 50% pain relief). Fifty-seven percent noted the Prolotherapy was very successful (greater than 75% pain relief). None indicated that the Prolotherapy treatment made them worse. One hundred percent had subsequently recommended Prolotherapy to someone.

FIGURE 7. Starting and ending pain, crunching, and stiffness levels before and after eceiving Hemwall-Hackett dextrose Prolotherapy in 7 patients with unresolved TMJ pain who were told that there were no other treatment options.

“No Other Treatment Options” Subgroup Analysis. Fifty percent (n=7) of the patients had been told by their doctors that there were no other treatment options for their pain prior to presenting for Prolotherapy. This group had average starting pain, stiffness, and crunching levels of 7.1, 5.9, and 5.7, respectively, before Prolotherapy. Their ending levels were 3.1, 3.1 and 3.3 for pain, stiffness and crunching levels after treatment (See Figure 7). Three of the patients noted less than 25% normal TMJ motion before Prolotherapy, but after Prolotherapy every patient said they had improved to greater than 25% of normal motion. Before Prolotherapy all seven patients were taking at least one pain medication while, after treatment, only two were taking medications. Five of the patients (71%) had 75% or greater pain relief, with the other two patients achieving 50-74% pain relief. Before Prolotherapy, 100% had depressed feelings, with three of the seven (43%) being on medications. All three on medications were able to get off medications after Prolotherapy and four of the seven (57%) no longer had depressed feelings (See Figure 8). In this group of seven patients, six felt they still had at least 75% of the benefit they received after the Prolotherapy treatments stopped.

Principal Findings. The results of this retrospective, uncontrolled, observational study, demonstrated that Prolotherapy helps decrease pain and improve the quality of life of patients with chronic temporomandibular joint symptoms. Decreases in pain, stiffness, and crunching levels of the TMJ were seen, even in patients who were told by their physicians that no other treatment options were available. Fifty-seven percent of the patients achieved greater than 75% pain relief with Prolotherapy and 93% of patients stated Prolotherapy relieved them of at least 50% of their pain. In regard to quality of life issues prior to receiving treatment, 50% had an overall disability of at least 50% (jaw motions restricted by about half). This decreased to 7% after Prolotherapy. Prolotherapy also caused clinically relevant improvements in patients’ TMJ range of motion, sleep, depressive and anxious feelings. Ninety percent of patients on medications at the start of Prolotherapy were able to decrease them by 75% or more. One hundred percent of patients said that dextrose Prolotherapy changed their life for the better. Eighteen months, on average, after their last Prolotherapy treatment, one hundred percent of patients said they had retained the majority of their benefits from the treatment.

FIGURE 8. Starting and ending depression levels before and after receiving Hemwall-Hackett dextrose Prolotherapy in 7 patients with unresolved TMJ pain who were told that there were no other treatment options.

Study Strengths and Weaknesses. Our study does not compare to clinical trial in which an intervention is investigated under controlled conditions. Instead, its aim was to document the response of patients with chronic temporomandibular joint dysfunction to the Hemwall-Hackett technique of dextrose Prolotherapy. Strengths of the study were that numerous quality of life parameters affecting TMJ sufferers were studied. Quality of life issues such as stiffness, range of motion, overall disability, sleep, anxiety, and depression—in addition to pain level—are important factors affecting an individual with chronic TMJ syndrome. Decreases in medication usage and additional pain management care were objective measures that were also documented.

Though the sample in this study was small (n=14), the quality of the cases treated is notable. The average person in this study had unresolved TMJ pain/dysfunction for 5.4 years and had been seen, on average, by four medical doctors prior to receiving Prolotherapy. Fifty percent of the cases were told that no other treatment options existed and 14% were told surgery was their only option. A follow-up time of eighteen months, on average, since their last treatment session provided a measure of the long-lasting effect of this modality.

Because this was a charity medical clinic with limited resources and personnel, the only therapy offered was Prolotherapy treatments given every three months. In private practice, the Hemwall-Hackett technique of dextrose Prolotherapy is typically given every four to six weeks. If a client is not improving or has poor healing ability, the Prolotherapy solutions may be changed or strengthened or the client is advised about additional measures to improve their overall health. This can include advice on diet, supplements, exercise, changes in medications, additional blood tests, physiotherapy, and/or other medical care. Often clients are weaned immediately off any anti-inflammatory and narcotic medications that inhibit the inflammatory response that is needed to achieve a healing effect from Prolotherapy. Since none of these were done, the results of this study are expected to represent the least optimum level of success achievable with Hemwall-Hackett dextrose Prolotherapy.

Another shortcoming of this study was the subjective nature of some of the evaluated parameters, including pain, anxiety, depression, and disability levels since the results relied on answers to questions by the patients. Further, any additional pain management care that the patients may have been receiving was not controlled. Lack of x-ray and MRI correlation for diagnosis and response to treatment, as well as a lack of physical examination documentation in the patients’ charts made categorization of the patients into various diagnostic parameters impossible.

Discussion. While the exact cause of chronic temporomandibular dysfunction is still debated, this study did demonstrate that the Hemwall-Hackett technique of dextrose Prolotherapy improves not only the pain level for those having chronic TMD, but also a host of other quality of life measures. The Hemwall-Hackett technique of dextrose Prolotherapy to the temporomandibular joint involves injections into the joint, as well as the fibro-osseous junction of the ligament and capsular attachments on the zygomatic arch, as well as the mandibular neck and condyle. Clearly the structural goal of Hemwall- Hackett dextrose Prolotherapy is to improve the stability of the TMJ by enhancing capsular and ligament strength. Congenital disorders that are characterized by overstretched ligaments, such as Ehlers- Danlos Syndrome, are typically predisposed to TMJ problems.¹⁸ Weakening of the TMJ capsule and ligament would explain a lot of the varied pathology involving TMD including joint subluxations, disc displacements, as well as muscle spasms and myofascial pain patterns.

The most common cause of TMJ pain is myofascial pain dysfunction syndrome and primarily involves the muscles of mastication.¹⁹ While massage, physiotherapy, pain medications, splints, surgeries, and other treatment modalities offer temporary help, they rarely cure the condition. ^20-22 A known cause of persistent muscle spasms and myofascial pain dysfunction is underlying ligament laxity.²³ By stimulating ligament and capsular repair for such cases, Prolotherapy would represent a more permanent solution.

The most common presentation of the TMJ is disc displacement.²⁴ In essence, this is when the articular disc, attached anteriorly to the superior head of the lateral pterygoid muscle and posteriorly to the retrodiscal tissue, moves out from between the condyle and the fossa, so that the mandible and temporal bone contact something other than the articular disc. In most instances of the disorder, the disc is displaced anteriorly upon translation. On opening, a “pop” or “click” can sometimes be heard—and usually felt—indicating the condyle is moving back onto the disc.²⁵

The TMJ is divided into an upper and lower joint cavity by a fibrocartilaginous articulating disc.²⁶ It is thicker posteriorly, thus making posterior dislocations more unlikely. Anteriorly, the disc is fused with the thin, loose, and fibrous joint capsule. The ligaments which contribute to the formation of the fibrous joint capsule and unite the articular bones are the temporomandibular (a.k.a. lateral), sphenomandibular, and stylomandibular. The temporomandibular ligament restrains the movement of the mandible and prevents compression of tissues behind the condyle.²⁷ Some authors note that this collateral ligament is simply a thickening of the joint capsule.²⁸ The joint capsule itself attaches to the articular eminence, the articular disc, and the neck of the mandibular condyle. Basically, the articular disc is a fibrous extension of the capsule between the two bones of the joint.²⁹ The sphenomandibular and stylomandibular ligaments keep the condyle, disc, and temporal bone firmly opposed and the multiple ligamentous attachments provide disc stability. Laterally, the disc is continuous with ligament tissue attaching it to the neck of the condyle.³⁰ While the cause of disc displacement is still under debate, an argument could be made that for many, it is injury to the joint capsule and TMJ ligament complex that is the issue. Anteriorly, the TMJ disc depends on the support of the joint capsule and TMJ ligament complex. If, for some reason, these became weakened, stretched, or torn, anterior disc dislocation would result. Only treatments designed to specifically strengthen and repair the injured joint capsule and ligament structures—such as Prolotherapy—would have a lasting effect.

Conclusions
In this observational study, the Hemwall- Hackett technique of dextrose Prolotherapy used on patients who presented with over five years of unresolved TMJ pain and dysfunction were shown to improve their quality of life even eighteen months subsequent to their last Prolotherapy session. All patients reported significantly reduced levels of pain, stiffness, crunching sensation, disability, depression, anxiety, medication, and other pain therapy. They also reported improved range of motion and sleep. The results confirm that Prolotherapy is a treatment that should be highly considered for people suffering with unresolved temporomandibular joint pain and dysfunction.

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